Skip to content

Solarc/SolRx 100-Series 110UVB

by Solarc Systems Inc

Solarc/SolRx 100-Series 110UVB is a Class II device made by Solarc Systems Inc, cleared under FDA 510(k) K061589 on 4 Aug 2006 and listed in FDA GUDID since 17 Sep 2016 (UDI-DI B219110UVB0), 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) K061589

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 NumberB219110UVB0 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061589 Date4 Aug 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061589 decided 4 Aug 2006 Active
  • FDA GUDID UDI-DI B219110UVB0 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K061589
  2. Listed FDA GUDID B219110UVB0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Solarc/SolRx 100-Series
Generic name
Ultraviolet phototherapy unit, professional
Model / reference
110UVB
Primary DI / UDI-DI
B219110UVB0
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

Similar devices

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

Other devices from Solarc Systems Inc

See all devices from Solarc Systems Inc →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)