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UVBioTek 20B

by Medtek Lighting Corp

UVBioTek 20B is a Class II device made by Medtek Lighting Corp, cleared under FDA 510(k) K134009 on 15 Oct 2014 and listed in FDA GUDID since 9 Feb 2017 (UDI-DI B343B20), 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) K134009

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 NumberB343B20 UDI-DI Date9 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK134009 Date15 Oct 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K134009 decided 15 Oct 2014 Active
  • FDA GUDID UDI-DI B343B20 listed 9 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K134009
  2. Listed FDA GUDID B343B20

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
UVBioTek
Generic name
Ultraviolet phototherapy unit, professional
Model / Ref / Catalog
20B
Primary DI / UDI-DI
B343B20
510(k) Number
FDA product code
FTC
GMDN term
Ultraviolet phototherapy unit, professional
Device class
Class II
Regulation number
878.4630
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 621 Square inch
Weight — 40 Pound

Related devices

Category: Ultraviolet phototherapy unit, professional

Cleared under the same submission (K134009)

and 1 more cleared under K134009

Similar devices

Other devices filed under FDA product code FTC (Light, Ultraviolet, Dermatological).

Other devices from Medtek Lighting Corp

  • Poly 7000A

    Class II

  • UVBioTek 3200B

    Class II

  • POLY Go Clear

    Class II

  • Poly Go 7000C

    Not classified

See all devices from Medtek Lighting Corp →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)