# K030338: Iclear Phototherapy System, Model FGCM0002

- Pathway: 510(k) (Special)
- Applicant: Curelight, Ltd.
- Decided: Feb 12, 2003 after 12 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.
742 later devices descend from it; 3 cite it directly.
0 of 743 devices 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 ClearLight: named in the summary without a submission number

## Most influential descendants
- K033946: Lovely System (2004), 737 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K042630: Revlight Skin Care System (2005), 402 descendants of its own
- K041969: Aurora DS (2004), 302 descendants of its own
- K050796: Aurora DS, DS Applicator (2005), 301 descendants of its own

## Indications for use
The iClear Phototherapy System is intended to provide phototherapeutic light to the body. The iCZear is generally indicated to treat dermatological conditions. The iClear is specifically indicated to treat moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K030338
Methodology: https://510kreport.com/methodology