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Conair MASK4

by Conair LLC.

Conair MASK4 is a Class II device made by Conair LLC., cleared under FDA 510(k) K183247 on 14 Mar 2019 and listed in FDA GUDID since 21 Aug 2024 (UDI-DI 00074108504753), 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) K183247

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 Number00074108504753 UDI-DI Date21 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183247 Date14 Mar 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183247 decided 14 Mar 2019 Active
  • FDA GUDID UDI-DI 00074108504753 listed 21 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K183247
  2. Listed FDA GUDID 00074108504753

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Conair
Generic name
Blue/red/infrared phototherapy lamp
Model / reference
MASK4
Primary DI / UDI-DI
00074108504753
510(k) Number
FDA product code
OHS
GMDN term
Blue/red/infrared phototherapy lamp
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blue/red/infrared phototherapy lamp

Other devices from Conair LLC.

See all devices from Conair LLC. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)