Identity
- Trade Name
- OMNIMAX S3 FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) and Infrared light (IR) for dermatological treatments by delivery of energy to the human skin. FDA UDI
- Model / Reference
- OMNIMAX-S3 FDA UDI
- Description
- The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) and Infrared light (IR) for dermatological treatments by delivery of energy to the human skin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290110240035 FDA UDI
- 510(k) Number
- K111303 FDA UDI
- FDA Product Code
- GEX 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-modality skin surface treatment system
Omnimax S3 by SharpLight Technologies 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
- 2941 handpiece — Cynosure, LLC · Class II
- Isolaz — Solta Medical, Inc. · Class II
- Handpiece 570 (6.4) for Harmony XL — ALMA LASERS LTD. · Class II
- Tip ClearLift QS KTP 532 4mm (Female) — ALMA LASERS LTD. · Class II
- ClearLift Depth Control Set for ClearLift QS 5x5 (No Lasing Tip) Female — ALMA LASERS LTD. · Class II
- OXYLIGHT — RAJA Medical · Class II
- 2940 handpiece — Cynosure, LLC · Class II
Cleared under the same submission
K111303 also covers:
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
- SharpLight Technologies Ltd.
Sources (1)
- FDA UDI e780f429-9bbe-445f-aca4-38192c65ed47 34 fields · synced Jun 1, 2026