Lutech LT-300 HD
Lutech LT-300 HD is a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Waverly Life Sciences LLC, cleared under FDA 510(k) K160380 on 13 May 2016 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI B299LT300HD0), 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 | NumberB299LT300HD0 | Date12 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160380 | Date13 May 2016 | StatusActive |
Official records
- FDA 510(k) database K160380
Across registries
- FDA 510(k) K160380 decided 13 May 2016 Active
- FDA GUDID UDI-DI B299LT300HD0 listed 12 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K160380
- Listed FDA GUDID B299LT300HD0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lutech
- Generic name
- Colposcope
- Model / reference
- LT-300 HD
- Primary DI / UDI-DI
- B299LT300HD0
- 510(k) Number
- FDA product code
- HEX
- GMDN term
- Colposcope
- Device class
- Class II
- Regulation number
- 884.1630
- GUDID distribution status
- In Commercial Distribution
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