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Harmony Lite System 110V For Alma Inc (purple)
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K233024
Identity
- Trade Name
- Harmony Lite System 110V For Alma Inc (purple) FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Model / Reference
- 1 FDA UDI
Identifiers
- Catalog Number
- AASP12121105 FDA UDI
- Primary DI / UDI-DI
- 17290110120938 FDA UDI
- 510(k) Number
- K141237 FDA UDI
- FDA Product Code
- ONF FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Harmony Lite System 110V For Alma Inc (purple) by Alma Lasers Ltd. — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230308 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243044 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233024 | Class II | Active |
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Manufacturer
- Manufacturer
- Alma Lasers Ltd.
- FDA Applicant
- Alma Lasers, Inc.
Sources (2)
- FDA UDI 61520dc8-c372-48b1-be5a-9caa542aae74 58 fields · synced Jun 19, 2026
- FDA 510(k) K230308 1 fields · synced Jun 5, 2026