Lt-300 Hd
510(k) K160380
Lt-300 Hd is a medical device (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Lutech Industries, cleared under FDA 510(k) K160380 on 13 May 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160380 | Date13 May 2016 | StatusActive |
Official records
- FDA 510(k) database K160380
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HEX
- FDA applicant
- Lutech Industries, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 884.1630
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K160380
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Lutech LT-300 HD | LT-300 HD | B299LT300HD0 | — | On the market |
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