October 27, 2023

Teoxane S.a.
℅ Aurelie Feroyard
Director of Regulatory Affairs
Gloster Biomedical International, LLC
577 North Hope Ave
Santa Barbara, California 93110

Re: P170002/S030
Trade/Device Name: RHA®3 dermal filler
Product Code: LMH
Filed: May 1, 2023

Dear Aurelie Feroyard:

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has
completed its review of your premarket approval application (PMA) supplement for the RHA®3 dermal
filler for expanding the indications to include injection to the lips. This device is indicated for injection in the
vermillion body, vermillion border and oral commissures to achieve lip augmentation and lip fullness in
adults aged 22 years or older. RHA®3 is also indicated for injection into the mid-to-deep dermis for the
correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults
aged 22 years or older. Based upon the information submitted, the PMA supplement is approved. You may
begin commercial distribution of the device in accordance with the conditions of approval described below.
Although this letter refers to your product as a device, please be aware that some approved products may
instead be combination products. The Premarket Approval Database available at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm identifies combination product
submissions.

The sale and distribution of this device are restricted to prescription use in accordance with 21 CFR 801.109
and under section 515(d)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (the act). FDA has
determined that these restrictions on sale and distribution are necessary to provide reasonable assurance of
the safety and effectiveness of the device. Your device is therefore a restricted device subject to the
requirements in sections 502(q) and (r) of the act, in addition to all other applicable requirements, including
those governing the manufacture, distribution, and marketing of devices.

Expiration dating for this device has been established and approved at 36 months. This is to advise you that
the protocol you used to establish this expiration dating is considered an approved protocol for the purpose of
extending the expiration dating as provided by 21 CFR 814.39(a)(7).

Continued approval of the PMA is contingent upon the submission of periodic reports, required under 21
CFR 814.84, at intervals of one year (unless otherwise specified) from the date of approval of the original

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.06.05
Silver Spring, MD 20993
www.fda.gov
P170002/S030 - Aurelie Feroyard Page 2

PMA. This report, identified as "Annual Report" and bearing the applicable PMA reference number, should
be submitted to the address below. The Annual Report should indicate the beginning and ending date of the
period covered by the report and must include the information required by 21 CFR 814.84.

In addition to the above, and in order to provide continued reasonable assurance of the safety and
effectiveness of the PMA device, under 21 CFR 814.82(a)(9), the Annual Report must include, separately for
each model number (if applicable), the number of devices sold and distributed during the reporting period,
including those distributed to distributors. The distribution data will serve as a denominator and provide
necessary context for FDA to ascertain the frequency and prevalence of adverse events, as FDA evaluates the
continued safety and effectiveness of the device.

You have agreed to provide the following information in a report, which may be followed by a PMA
supplement where applicable.

The Post-Approval Study for the validation of the Teoxane Lip Fullness Scale (TLFS) will include two
protocols:
1. Live scale validation
2. Photographic scale validation

Subjects will follow these demographic requirements (for photographic and live validation):
x All grades of the scale should be represented
x At least 20% of subjects with Fitzpatrick Skin Type (FST) IV-VI
x At least 10% of subjects with FST V/VI including subjects with FST V and FST VI
x At least 10% of subjects of Hispanic ethnicity
x At least 3% of subjects of Asian descent

Live validation:
x 80 to 150 subjects
x 5 to 15 independent scale evaluators
Photographic validation:
x 75 to 150 subject photographs
x 3 to 8 independent scale evaluators

Each validation will include two sessions 14 to 30 days apart.

Data analysis and acceptance criteria for photographic and live validation:
x Intra-rater kappa per Cichetti-Allison formula: overall mean (all raters) >0.70 (2-sided 95%
confidence interval for information)
x Inter-rater: Intraclass Correlation Coefficient (ICC): overall criteria ICC >0.70 (2-sided 95%
confidence interval for information)
x Percentage of intra-rater and inter-rater exact agreement:
o Overall (all raters, all grades): ≥70% (2-sided 95% confidence interval for information)
o For each grade (all raters): ≥70% (2-sided 95% confidence interval for information)
P170002/S030 - Aurelie Feroyard Page 3

In addition, you must submit the following for these studies:

x Within 90 days of receipt of the approval letter, you must submit a PMA supplement that includes
complete protocols for the post-approval studies
x You must submit PAS Progress Reports every six months during the first two years and annually
thereafter
x You must submit the Final PAS Report three (3) months from study completion

Be advised that failure to comply with any post-approval requirement, including test protocol, sample size,
demographic requirements, pass/fail requirements outlined above, and required timeline for data accrual and
study completion per the approved protocol, constitutes grounds for FDA withdrawal of approval of the
PMA in accordance with 21 CFR 814.82(c) and 21 CFR 814.46(a)(2).

FDA would like to remind you that you are required to submit PAS Progress Reports every six months
during the first two years and annually thereafter. The reports should clearly be identified as Post-Approval
Study Report. A copy, identified as "PMA Post-Approval Study Report" and bearing the applicable PMA
reference number, should be submitted to the address below. For more information on post-approval studies,
see the FDA guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by PMA
Order"
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070974.htm

Within 90 days of your receipt of this letter, you must submit a PMA supplement that includes a complete
protocol of your post-approval study. Your PMA supplement should be clearly labeled as a "Post-Approval
Study Protocol" and submitted to the address below. Please reference the PMA number above to facilitate
processing. If there are multiple protocols being finalized after PMA approval, please submit each protocol
as a separate PMA supplement. For more information on post-approval studies, see the FDA guidance
document entitled, "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
(www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070974.htm#2).

This is a reminder that as of September 24, 2014, class III devices are subject to certain provisions of the
final Unique Device Identification (UDI) rule. These provisions include the requirement to provide a UDI on
the device label and packages (21 CFR 801.20), format dates on the device label in accordance with 21 CFR
801.18, and submit data to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830
Subpart E). Additionally, 21 CFR 814.84 (b)(4) requires PMA annual reports submitted after September 24,
2014, to identify each device identifier currently in use for the subject device, and the device identifiers for
devices that have been discontinued since the previous periodic report. It is not necessary to identify any
device identifier discontinued prior to December 23, 2013. Combination Products may also be subject to
UDI requirements (see 21 CFR 801.30). For more information on these requirements, please see the UDI
website available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/unique-device-identification-udi-system.

Before making any change affecting the safety or effectiveness of the PMA device, you must submit a PMA
supplement or an alternate submission (30-day notice) in accordance with 21 CFR 814.39. All PMA
supplements and alternate submissions (30-day notice) must comply with the applicable requirements in 21
CFR 814.39. Additional information about changes that may require a PMA supplement are provided in the
FDA guidance document entitled, "Modifications to Devices Subject to Premarket Approval (PMA) - The
PMA Supplement Decision-Making Process" https://www.fda.gov/media/81431/download.
P170002/S030 - Aurelie Feroyard Page 4

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part
820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a
change requires premarket review, the QS regulation requires device manufacturers to review and approve
changes to device design and production and process controls (21 CFR 820.30 and 21 CFR 820.70) and
document changes and approvals in the device master record (21 CFR 820.181).

You are reminded that many FDA requirements govern the manufacture, distribution, and marketing of
devices. For example, in accordance with the Medical Device Reporting (MDR) regulation, 21 CFR 803.50
and 21 CFR 803.52 for devices or post-marketing safety reporting (21 CFR Part 4, Subpart B) for
combination products, you are required to report adverse events for this device. Manufacturers of medical
devices, including in vitro diagnostic devices, are required to report to FDA no later than 30 calendar days
after the day they receive or otherwise becomes aware of information, from any source, that reasonably
suggests that one of their marketed devices:

1. May have caused or contributed to a death or serious injury; or

2. Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to
cause or contribute to a death or serious injury if the malfunction were to recur.

Additional information on MDR, including how, when, and where to report, is available at
https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-
medical-device-problems and on combination product post-marketing safety reporting is available at
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products.

In accordance with the recall requirements specified in 21 CFR 806.10 for devices or the post-marketing
safety reporting requirements (21 CFR Part 4, Subpart B) for combination products, you are required to
submit a written report to FDA of any correction or removal of this device initiated by you to: (1) reduce a
risk to health posed by the device; or (2) remedy a violation of the act caused by the device which may
present a risk to health, with certain exceptions specified in 21 CFR 806.10(a)(2). Additional information on
recalls is available at
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industry-guidance-recalls.

CDRH does not evaluate information related to contract liability warranties. We remind you, however, that
device labeling must be truthful and not misleading. CDRH will notify the public of its decision to approve
your PMA by making available, among other information, a summary of the safety and effectiveness data
upon which the approval is based. The information can be found at
https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/pma-approvals. Written
requests for this information can also be made to the Food and Drug Administration, Dockets Management
Branch, (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The written request should
include the PMA number or docket number. Within 30 days from the date that this information is placed on
the Internet, any interested person may seek review of this decision by submitting a petition for review under
section 515(g) of the act and requesting either a hearing or review by an independent advisory committee.
FDA may, for good cause, extend this 30-day filing period.
P170002/S030 - Aurelie Feroyard Page 5

Failure to comply with any post-approval requirement constitutes a ground for withdrawal of approval of a
PMA. The introduction or delivery for introduction into interstate commerce of a device that is not in
compliance with its conditions of approval is a violation of law.

You are reminded that, as soon as possible and before commercial distribution of your device, you must
submit an amendment to this PMA submission with a copy of all final labeling. Final labeling that is
identical to the labeling approved in draft form will not routinely be reviewed by FDA staff when
accompanied by a cover letter stating that the final labeling is identical to the labeling approved in draft
form. If the final labeling is not identical, any changes from the final draft labeling should be highlighted and
explained in the amendment.

All required documents should be submitted, unless otherwise specified, to the address below and should
reference the above PMA number to facilitate processing.

U.S. Food and Drug Administration

Center for Devices and Radiological Health
Document Control Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

If you have any questions concerning this approval order, please contact Scott Herting at 240-402-6148 or
Scott.Herting@fda.hhs.gov.

Sincerely,

David Krause -S
IRU Cynthia J. Chang, Ph.D.
Director
DHT4B: Division of Infection Control
and Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health