Identity
- Trade Name
- OMNIMAX S4 FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) Infrared light (IR) and Laser light technologies for dermatological treatments by delivery of energy to the human skin. FDA UDI
- Model / Reference
- OMNIMAX-S4 FDA UDI
- Description
- The Dermatologic Treatment Systems (DTS) device family and optional hand pieces, including Intensive Pulse Light (IPL) Infrared light (IR) and Laser light technologies for dermatological treatments by delivery of energy to the human skin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290110240042 FDA UDI
- 510(k) Number
- K111303 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological solid-state laser 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: Dermatological solid-state laser system
Omnimax S4 by SharpLight Technologies Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dermatological solid-state laser system.
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- Splendor X — Bios, Inc. · Class II
- EPY-50 — DDC TECHNOLOGIES, INC. · Class II
- Canister HFC-134a /980g, ALUM, 15 pack — Candela Corporation · 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 6171295d-1f84-4cda-b8bb-b61b9d0e6d4a 34 fields · synced May 30, 2026