# K041569: CLEAR100 Phototherapy System, Model FGCM0002

- Pathway: 510(k) (Special)
- Applicant: Curelight, Ltd.
- Decided: Jun 30, 2004 after 20 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CureLight Ltd.'s ReClear: named in the summary without a submission number

## Indications for use
The Clear100TM Phototherapy System (" Clearl00TM ") is intended to provide phototherapeutic light to the body. The Clear100 TM is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared 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/K041569
Methodology: https://510kreport.com/methodology