# K063112: Revlite Q-Switched ND:Yag Laser

- Pathway: 510(k) (Special)
- Applicant: Hoya Conbio, Inc.
- Decided: Dec 1, 2006 after 51 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: 1 generation back to K014234 (2002). 1 ancestor in all.
169 later devices descend from it; 1 cites it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 1.
- (no number) Focus Medical NaturaLase 1064 2 Joule Laser System: named in the summary without a submission number

## Most influential descendants
- K063834: Revlite C6 Q-Switched ND:Yag Laser System (2007), 168 descendants of its own
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 descendants of its own
- K103455: Spectra Laser System (2011), 92 descendants of its own
- K113588: Spectra Laser System (2012), 82 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
The RevLite Q-Switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: 1064 nm wavelength: Tattoo Removal: Dark Ink: (Black & Blue) Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation. Skin resurfacing procedures for the treatment of acne scars and wrinkles 532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece): Tattoo Removal: Light Ink (Red, Sky Blue, Green) Treatment of Vascular Lesions including, but not limited to: * port wine birthmarks * telangiectasias * spider angioma * cherry angioma spider nevi Treatment of Pigmented Lesions including, but not limited to: * cafe-au-lait birthmarks * solar lentiginos * senile lentiginos * Becker's nevi * Freckles * Nevus spilus Skin resurfacing procedures for the treatment of acne scars and wrinkles

Source page: https://510kreport.com/device/K063112
Methodology: https://510kreport.com/methodology