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Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / Pro
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / Pro FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Model / Reference
- 02 FDA UDI
Identifiers
- Catalog Number
- AAHP08031503WR0002 FDA UDI
- Primary DI / UDI-DI
- 17290110121942 FDA UDI
- 510(k) Number
- K072564 FDA UDI
- FDA Product Code
- GEX FDA UDIFTC FDA UDIHHR FDA UDILNK FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI878.4630 FDA UDI884.4550 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-modality skin surface treatment system
Handpiece ER iPixel 4Hz Er:YAG 2940 High Power Harmony XL / Pro 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.
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- 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
K072564 also covers:
- Alma Beauty Rejuve System 120V — ALMA LASERS LTD.
- ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female — ALMA LASERS LTD.
- Handpiece 515 (6.4) for Harmony XL 50000 pulses — ALMA LASERS LTD.
- Handpiece 540 (6.4) for Harmony XL 50000 pulses — ALMA LASERS LTD.
- Handpiece 570 (6.4) for Harmony XL — ALMA LASERS LTD.
- Handpiece 780 ST (6.4) for Harmony XL — ALMA LASERS LTD.
- Handpiece Acne 420-950nm (6.4) for Harmony XL — ALMA LASERS LTD.
- Handpiece Cooled 515 (3) for Harmony XL 50000 pulses — ALMA LASERS LTD.
- Handpiece Cooled 540 (3) for Harmony XL 50000 pulses — ALMA LASERS LTD.
- Handpiece Cooled 570 (3) for Harmony XL 50000 pulses — ALMA LASERS LTD.
- Handpiece Cooled Dye SR (3) For Lite Pro — ALMA LASERS LTD.
- Handpiece Cooled Dye VL (3) For HXL — 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 2f528dfe-c08c-4c49-9066-2ca581c2c1f7 34 fields · synced May 31, 2026