Identity
- Trade Name
- Opus Colibri 1mm Single-use Tip Set (X6) FDA UDI
- Generic Name
- Radio-frequency skin/body contouring system FDA UDI
- Device Name
- Opus Colibri 1mm Single-use Tip Set of 6 units FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Opus Colibri 1mm Single-use Tip Set of 6 units FDA UDI
Identifiers
- Catalog Number
- AACL03052003 FDA UDI
- Primary DI / UDI-DI
- 17290110122161 FDA UDI
- FDA Product Code
- GEI FDA UDINUV FDA UDIISA FDA UDIIMI FDA UDI
- GMDN Term
- Radio-frequency skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4810 FDA UDI890.5660 FDA UDI890.5300 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Opus Colibri 1mm Single-use Tip Set (X6) by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Alma Lasers Ltd.
Sources (1)
- FDA UDI 690b18fc-b173-4bec-884a-527557737335 35 fields · synced May 30, 2026