# K013623: Clearlight Phototheraphy System, Model CL 420

- Pathway: 510(k) (Traditional)
- Applicant: Curelight, Ltd.
- Decided: Aug 16, 2002 after 284 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.
856 later devices descend from it; 10 cite it directly.
0 of 857 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) Avex Industries, Inc.’s Phototherapeutix: named in the summary without a submission number
- (no number) National Biological Corporation’s Derma-Wand: named in the summary without a submission number
- (no number) PhotoMedex, Inc.’s XTrac Excimer Laser System, Model AL 7000: named in the summary without a submission number
- (no number) Respironics, Inc.’s Wallaby 3 Phototherapy System: named in the summary without a submission number

## Most influential descendants
- K033946: Lovely System (2004), 737 descendants of its own
- K030883: Omnilux Blue (2003), 524 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K040103: Soundskin Phototherapy System (2005), 403 descendants of its own
- K042630: Revlight Skin Care System (2005), 402 descendants of its own

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

Source page: https://510kreport.com/device/K013623
Methodology: https://510kreport.com/methodology