Skip to content

Dr Yglo 1

by TheOTCLab B.V.

Dr Yglo 1 is a Class II device made by TheOTCLab B.V., cleared under FDA 510(k) K210529 on 6 May 2021 and listed in FDA GUDID since 23 Apr 2025 (UDI-DI 08720618589002), 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) K210529

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 Number08720618589002 UDI-DI Date23 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210529 Date6 May 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210529 decided 6 May 2021 Active
  • FDA GUDID UDI-DI 08720618589002 listed 23 Apr 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210529
  2. Listed FDA GUDID 08720618589002

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dr Yglo
Generic name
Wart-removal cryogenic kit
Model / reference
1
Primary DI / UDI-DI
08720618589002
FDA product code
GEH
GMDN term
Wart-removal cryogenic kit
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wart-removal cryogenic kit

Cleared under the same submission (K210529)

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)