Identity
- Trade Name
- NIR Face (6) HP FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AAIP24102207 FDA UDI
- Primary DI / UDI-DI
- 07290110123444 FDA UDI
- 510(k) Number
- K230308 FDA UDI
- FDA Product Code
- GEX FDA UDIILY FDA UDIONF FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI890.5500 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
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: Multi-modality skin surface treatment system
NIR Face (6) HP by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-modality skin surface treatment system.
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- Deep2 — Termosalud · Class I
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- Isolaz — Solta Medical, Inc. · Class II
Cleared under the same submission
K230308 also covers:
- ALMA HARMONY CONSOLE — ALMA LASERS LTD.
- ALMA HARMONY CONSOLE WITH GREEN DIODE — ALMA LASERS LTD.
- Iris Acne IPL HP — ALMA LASERS LTD.
- Iris Dye VL IPL HP — ALMA LASERS LTD.
- Iris SHR Pro (6.4) Cooled IPL HP — ALMA LASERS LTD.
- Iris SR IPL HP — ALMA LASERS LTD.
- Iris VL/PL IPL HP — ALMA LASERS LTD.
- VascuPen Diode laser 520nm HP — ALMA LASERS 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
- Alma Lasers Ltd.
Sources (1)
- FDA UDI 5ec5f0b9-c853-45bd-a3b8-9a8e73b3768e 34 fields · synced Jun 8, 2026