Thermage Flx

FDA UDI

Class I (US FDA UDI)

by Solta Medical, Inc.

Identity

Trade Name: THERMAGE FLX FDA UDI
Generic Name: Radio-frequency skin/body contouring system FDA UDI
Device Name: COUPLING GEL, 60G FDA UDI
Model / Reference: TF-3 FDA UDI
Description: COUPLING GEL, 60G FDA UDI

Identifiers

Catalog Number: TF-3 FDA UDI
Primary DI / UDI-DI: 00816995026341 FDA UDI
FDA Product Code: ISA FDA UDI
GEI FDA UDI
GMDN Term: Radio-frequency skin/body contouring system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5660 FDA UDI
878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency skin/body contouring system

Thermage Flx by Solta Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency skin/body contouring system.

Density B-Tip — Jeisys Medical Incorporated · Class II
truSculpt — CUTERA, INC. · Class II
FAQ 102 — FOREO INC · Class II
(MP)2 APPLICATOR SERVICE PACK, Bliss — Venus Concept Inc. · Class II
VIVEVE Hand Piece S — VIVEVE, INC. · Class II
Triworks — Triworks Group Srl · Class II
OptiPLUS — Bios, Inc. · Class II
Universal Electrosurgical Pad (3M REF 9160) — VIVEVE, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Solta Medical, Inc.

Sources (1)

FDA UDI 0b835d10-95f6-4528-b7fc-bea7975e6486 34 fields · synced Jun 1, 2026