# K083899: Revlite Q-Switched ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Hoya Conbio, Inc.
- Decided: Jun 1, 2009 after 154 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: 15 generations back to K943450 (1995). 248 ancestors in all.
198 later devices descend from it; 5 cite it directly.
0 of 447 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 1.
- K033461: Candela Vbeam Pulse Dye Laser System, Candela Corp. (2004) Summary page 1.
- K021180: Candela Vbeam Pulsed Dye Laser System, Candela Corp. (2002) Summary page 1.
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam), Candela Corp. (2002)
- K053608: Cynosure Photogenica V-Star Laser, Cynosure, Inc. (2006) Summary page 1.
- K964074: Diolite 532, Iriderm Div. (1997) Summary page 1.

## Most influential descendants
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor (2010), 92 descendants of its own
- K121346: Picosure Workstation (2012), 87 descendants of its own
- K142372: Pico Way Laser System (2014), 70 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own

## Indications for use
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: blue and black) * Nevus of Ota * Removal or lightening of hair with or without adjuvant preparation. * Skin Resurfacing for Acne Scars and Wrinkles * Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength) 532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece) * Tattoo removal (light ink: red, sky blue, green) * Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi * Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus · Skin Resurfacing for Acne Scars and Wrinkles · Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength) * Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar

Source page: https://510kreport.com/device/K083899
Methodology: https://510kreport.com/methodology