Identity
- Trade Name
- Reverso 160 Pin Tip Head FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator tip FDA UDI
- Model / Reference
- IS-FG-00003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018977026 FDA UDI
- 510(k) Number
- K212107 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin contouring system applicator tip 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Radio-frequency skin contouring system applicator tip
Reverso 160 Pin Tip Head by Intelis Instruments Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin contouring system applicator tip.
- triFX — POLLOGEN LTD · Class II
- triFX — POLLOGEN LTD · Class II
- INTRAgen Tip — Jeisys Medical Inc. · Class II
- Morpheus8 — Inmode MD , Ltd. · Class II
- VOLNEWMER F tip(D) — CLASSYS Inc. · Class II
- VOLNEWMER S tip — CLASSYS Inc. · Class II
- Morpheus8 Prime 12 pin TIP — Inmode MD , Ltd. · Class II
- triFX — POLLOGEN LTD · Class II
Cleared under the same submission
K212107 also covers:
- INDIBA DEEP CARE - REVERSO — INDIBA SA.
- INDIBA DEEP CARE - REVERSO - Applicator handle — INDIBA SA.
- INDIBA DEEP CARE - REVERSO - Tip 160 pins — INDIBA SA.
- INDIBA DEEP CARE - REVERSO - Tip 176 pins — INDIBA SA.
- INDIBA DEEP CARE - REVERSO - Tip 44 pins — INDIBA SA.
- INDIBA DEEP CARE - REVERSO - Tip 80 pins — INDIBA SA.
- INDIBA DEEP CARE - REVERSO - Tip 88 pins — INDIBA SA.
- Reverso — INTELIS INSTRUMENTS LTD
- Reverso 176 Pin Tip Head — INTELIS INSTRUMENTS LTD
- Reverso 44 Pin Tip Head — INTELIS INSTRUMENTS LTD
- Reverso 80 Pin Tip Head — INTELIS INSTRUMENTS LTD
- Reverso 88 Pin Tip Head — INTELIS INSTRUMENTS 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
- Intelis Instruments Ltd
Sources (1)
- FDA UDI 64681e1a-3228-4a39-adb4-4ea300061714 33 fields · synced Jun 8, 2026