Skip to content

Lutech LT-300 SD

by Waverly Life Sciences LLC

Lutech LT-300 SD is a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Waverly Life Sciences LLC, cleared under FDA 510(k) K170446 on 21 May 2017 and listed in FDA GUDID since 29 Jun 2017 (UDI-DI B299LT300SD0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K170446

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB299LT300SD0 UDI-DI Date29 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170446 Date21 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170446 decided 21 May 2017 Active
  • FDA GUDID UDI-DI B299LT300SD0 listed 29 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170446
  2. Listed FDA GUDID B299LT300SD0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lutech
Generic name
Colposcope
Model / reference
LT-300 SD
Primary DI / UDI-DI
B299LT300SD0
510(k) Number
FDA product code
HEX
GMDN term
Colposcope
Device class
Class II
Regulation number
884.1630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Colposcope

Similar devices

Other devices filed under FDA product code HEX (Colposcope (And Colpomicroscope)).

Other devices from Waverly Life Sciences LLC

  • Lutech LT-300 HD

    Class II

Properties

  • Serial number
Other properties (14, all answered No)