Identity
- Trade Name
- Reverso Applicator FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system applicator FDA UDI
- Model / Reference
- IS-FG-00002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018977019 FDA UDI
- 510(k) Number
- K212107 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
No
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
Reverso Applicator by Intelis Instruments Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 160 Pin Tip Head — 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
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 |
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Manufacturer
- Manufacturer
- Intelis Instruments Ltd
Sources (1)
- FDA UDI d1c0896f-a234-4fcc-a33b-43391d1762e7 33 fields · synced Jun 8, 2026