# K033183: Reclear Phototherapy System, Model FGCM0012

- Pathway: 510(k) (Traditional)
- Applicant: Curelight, Ltd.
- Decided: Apr 15, 2004 after 197 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001179 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001179: Super Nova, Acubeam, Light Force Therapy, Inc. (2000) Summary page 1.
- K020017: Medx 1000 Series, Medx Electronics, Inc. (2002) Summary page 2.
- K020851: TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B, CQG-270A/B, CQG-222D, C&H International (2002) Summary page 2.
- K030338: Iclear Phototherapy System, Model FGCM0002, Curelight, Ltd. (2003) Summary page 2.

## Indications for use
The ReClearTrm Phototherapy System ("ReClearTM ") is intended to provide phototherapeutic light to the body. The ReClearTM is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and IR light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

Source page: https://510kreport.com/device/K033183
Methodology: https://510kreport.com/methodology