Identity
- Trade Name
- Twain Evo FDA UDI
- Generic Name
- Light-energy skin surface treatment system applicator FDA UDI
- Device Name
- Intense Pulsed Light handpiece 400 nm 48x13 (for Discovery Pico family) FDA UDI
- Model / Reference
- OAM002011 FDA UDI
- Description
- Intense Pulsed Light handpiece 400 nm 48x13 (for Discovery Pico family) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08059173390076 FDA UDI
- 510(k) Number
- K160368 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Light-energy skin surface treatment system applicator 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
Yes
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
Yes
FDA UDI
Category: Light-energy skin surface treatment system applicator
A comprehensive 2-3 paragraph SEO description written in clear, natural language. The device is a skin surface treatment system that conducts one or more generated light energies for ablative and non-ablative treatment of various skin conditions.
Similar devices
Also classified as Light-energy skin surface treatment system applicator.
- F-SR — FORMATK SYSTEMS LTD · Class II
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- F-HR — FORMATK SYSTEMS LTD · Class II
- B-SR — FORMATK SYSTEMS LTD · Class II
- intenseIR — VYDENCE MEDICAL · Class II
- Dynatron Tri-Wave Light Pads — Dynatronics Corp. · Class II
- SR — FORMATK SYSTEMS LTD · Class II
- illuvinate Starter Kit — Luma Therapeutics · Class II
Cleared under the same submission
K160368 also covers:
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
- Twain Evo — Quanta System Spa
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Quanta System Spa
Sources (1)
- FDA UDI cc77472a-03f0-4773-b7eb-e84cc0eead88 34 fields · synced Jul 21, 2026