Identity
- Trade Name
- INDIBA DEEP CARE - REVERSO FDA UDI
- Generic Name
- Intradermal radio-frequency ablation system FDA UDI
- Device Name
- Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. FDA UDI
- Model / Reference
- IDC0400USA FDA UDI
- Description
- Radiofrequency devices. Electrosurgical cutting and coagulation device and accessories. FDA UDI
Identifiers
- Catalog Number
- REVERSO FDA UDI
- Primary DI / UDI-DI
- 08434251002636 FDA UDI
- 510(k) Number
- K212107 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Intradermal radio-frequency ablation system 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intradermal radio-frequency ablation system
Indiba Deep Care - Reverso by Indiba Sa. — 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 - 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
- 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 |
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Manufacturer
- Manufacturer
- Indiba Sa.
Sources (1)
- FDA UDI 2a984fa5-7eda-48c3-bfdf-ed291f7a28bf 35 fields · synced May 30, 2026