← Back to catalogue
INDIBA DEEP CARE - REVERSO - Applicator handle
FDA UDIClass II (US FDA UDI)
by Indiba Sa.
Identity
- Trade Name
- INDIBA DEEP CARE - REVERSO - Applicator handle FDA UDI
- Generic Name
- Intradermal radio-frequency ablation system FDA UDI
- Device Name
- Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips. FDA UDI
- Model / Reference
- ACC1018USA FDA UDI
- Description
- Radiofrequency devices. Accessory intended to transmit the electric current generated by the RF generator to the tips. FDA UDI
Identifiers
- Catalog Number
- REVERSO applicator handle FDA UDI
- Primary DI / UDI-DI
- 08434251002667 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 - Applicator handle by Indiba Sa. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intradermal radio-frequency ablation system.
- QUADESSY Set Package — CLASSYS Inc. · Class II
- AcuTron Handpiece — CLASSYS Inc. · Class II
- Secret RF Small Handpiece — CLASSYS Inc. · Class II
- Secret DUO Set Package — CLASSYS Inc. · Class II
- AGNES — AGNES MEDICAL CO., LTD. · Class II
- VIVACE ULTRA — Aesthetics Biomedical · Class II
- VIVACE ULTRA — Aesthetics Biomedical · Class II
- Fraxis Duo Needle Handpiece — CLASSYS Inc. · Class II
Cleared under the same submission
K212107 also covers:
- INDIBA DEEP CARE - REVERSO — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Indiba Sa.
Sources (1)
- FDA UDI 7a556242-931a-4f7e-97bd-48214573383e 35 fields · synced May 30, 2026