Identity
- Trade Name
- FormaV Applicator FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system applicator FDA UDI
- Device Name
- FormaV (Plus 90) Applicator FDA UDI
- Model / Reference
- AG606798A FDA UDI
- Description
- FormaV (Plus 90) Applicator FDA UDI
Identifiers
- Catalog Number
- AG606798A FDA UDI
- Primary DI / UDI-DI
- 07290016633535 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system applicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin surface treatment system applicator
FormaV Applicator by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin surface treatment system applicator.
- Silk'n — Silk'N Beauty , Ltd. · Class II
- Legend Pro — POLLOGEN LTD · Class II
- Venus Versa — Venus Concept Inc. · Class II
- Legend Pro — POLLOGEN LTD · Class II
- Legend Pro — POLLOGEN LTD · Class II
- Silk'n — Silk'N Beauty , Ltd. · Class II
- Venus Viva — Venus Concept Inc. · Class II
- EndyMed Pure FSR Handpiece — ENDYMED MEDICAL LTD · Class II
Cleared under the same submission
K153568 also covers:
K201150 also covers:
K221571 also covers:
- Diolaze XL 755/810 Applicator — Inmode MD , Ltd.
- Diolaze XL 810 Applicator — Inmode MD , Ltd.
- Diolaze XL 810/1064 Applicator — Inmode MD , Ltd.
- Diolaze XL Max Applicator — Inmode MD , Ltd.
- Envision System — Inmode MD , Ltd.
- FRACTORA 3D-90 Tip — Inmode MD , Ltd.
- Fusion Dark Applicator — Inmode MD , Ltd.
- Fusion Light Applicator — Inmode MD , Ltd.
- InMode OP — Inmode MD , Ltd.
- Lumecca I — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA UDI 716a54e3-be52-4dbf-b83f-8e3f607dccd1 37 fields · synced May 30, 2026