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Cleane

by Medicon Co., Ltd.

Cleane is a blue-light phototherapy lamp (FDA Class II; FDA product code OZC, Over The Counter Thermal Treatment For Acne.) made by Medicon Co., Ltd., cleared under FDA 510(k) K111341 on 29 Feb 2012 and listed in FDA GUDID since 15 Aug 2020 (UDI-DI 08809216198103), 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) K111341

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 Number08809216198103 UDI-DI Date15 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK111341 Date29 Feb 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K111341 decided 29 Feb 2012 Active
  • FDA GUDID UDI-DI 08809216198103 listed 15 Aug 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K111341
  2. Listed FDA GUDID 08809216198103

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Blue-light phototherapy lamp, home-use
Model / reference
CLEANE
Primary DI / UDI-DI
08809216198103
510(k) Number
FDA product code
OZC
GMDN term
Blue-light phototherapy lamp, home-use
Device class
Class II
Regulation number
890.5740
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blue-light phototherapy lamp, home-use

Other devices from Medicon Co., Ltd.

See all devices from Medicon Co., Ltd. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)