# K042630: Revlight Skin Care System

- Pathway: 510(k) (Traditional)
- Applicant: Skincare Technology, Inc.
- Decided: Jun 27, 2005 after 273 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: 9 generations back to K943450 (1995). 121 ancestors in all.
402 later devices descend from it; 6 cite it directly.
0 of 524 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)
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 1.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 1.
- K013623: Clearlight Phototheraphy System, Model CL 420, Curelight, Ltd. (2002)
- K022266: Aurora SR, Syneron Medical, Ltd. (2002) Summary page 1.
- K033946: Lovely System, Msq (M2), Ltd. (2004) Summary page 1.
- K040103: Soundskin Phototherapy System, Bhc International, Ltd. (2005). Cleared while this submission was under review Summary page 1.
- K935459: Omron Massager Model HM-45, Omron Healthcare, Inc. (1994) Summary page 1.

## Most influential descendants
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K060792: Illumimed (2006), 115 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own

## Indications for use
RevLight is intended for use to provide LED light to the body. Facial massage. Used with the RevLight, are generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Used with the RevLight, are generally indicated to provide topical heating to promote increased blood flow, for temporary relaxation of muscle and relief of pain. Used with the RevLight, are generally indicated to provide topical heating to promote increased blood flow, for temporary relaxation of muscle and relief of pain.

Source page: https://510kreport.com/device/K042630
Methodology: https://510kreport.com/methodology