Identity
- Trade Name
- Pixel CO2 Hand Piece 9x9 & 7x7 alma FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AACO04090802 FDA UDI
- Primary DI / UDI-DI
- 17290110120778 FDA UDI
- 510(k) Number
- K103501 FDA UDI
- FDA Product Code
- HQF FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4390 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-modality skin surface treatment system
Pixel CO2 Hand Piece 9x9 & 7x7 alma by Alma Lasers Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-modality skin surface treatment system.
- Deep2 — Termosalud · Class I
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- Isolaz — Solta Medical, Inc. · Class II
- OXYLIGHT — RAJA Medical · Class II
- 2940 handpiece — Cynosure, LLC · Class II
- Deep2 — Termosalud · Class I
- ZYE ALX — VYDENCE MEDICAL · Class II
- Isolaz — Solta Medical, Inc. · Class II
Cleared under the same submission
K103501 also covers:
- Alma Pixel 30W 120V 50/60Hz Black (Inc) — ALMA LASERS LTD.
- CO2 Lite Scan (rev.2) — ALMA LASERS LTD.
- CO2 LiteScan Applicator FOR INC — ALMA LASERS LTD.
- CO2 New Scanner system 100-120V 30W — ALMA LASERS LTD.
- CO2 New Scanner system 100-120V 70W — ALMA LASERS LTD.
- CO2 Scanner system 100-120V 30W (Modem) — ALMA LASERS LTD.
- FemiLift Handpiece — ALMA LASERS LTD.
- FemiLift Hygienic, Single Use Probe — ALMA LASERS LTD.
- FemiLift Hygienic, Single Use Probe Set (6 units) — ALMA LASERS LTD.
- FemiLift Sleeve — ALMA LASERS LTD.
- FemiLift Sleeve — ALMA LASERS LTD.
- FemiLift Sleeve — 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 638e47bd-1b85-41f1-b34f-6e5b9186339d 34 fields · synced Jun 8, 2026