Dermalux Tri-Wave MD MKII
Dermalux Tri-Wave MD MKII (1000021) is a Class II device made by Aesthetic Technology, Ltd., cleared under FDA 510(k) K240222 on 4 Jun 2024 and listed in FDA GUDID since 2 Sep 2025 (UDI-DI 05060762460011), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060762460011 | Date2 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK240222 | Date4 Jun 2024 | StatusActive |
Official records
- AccessGUDID record 05060762460011
- FDA 510(k) database K240222
Across registries
- FDA 510(k) K240222 decided 4 Jun 2024 Active
- FDA GUDID UDI-DI 05060762460011 listed 2 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K240222
- Listed FDA GUDID 05060762460011
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dermalux
- Generic name
- Blue/red/infrared phototherapy lamp
- Model / Ref / Catalog
- Tri-Wave MD MKII, 1000021
- Primary DI / UDI-DI
- 05060762460011
- 510(k) Number
- FDA product code
- GEX, ILY
- GMDN term
- Blue/red/infrared phototherapy lamp
- Device class
- Class II
- Regulation number
- 878.4810, 890.5500
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 679.7 MillimeterHeight — 1087.4 MillimeterWidth — 517.7 MillimeterWeight — 55 Kilogram
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