# K133254: Revlite Q-Switched ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Mar 5, 2014 after 134 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: 17 generations back to K943450 (1995). 268 ancestors in all.
57 later devices descend from it; 8 cite it directly.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor, Hoya Photonics, Inc. (2010) Summary page 1.
- K113588: Spectra Laser System, Lutronic Corporation (2012) Summary page 1.
- K061436: Palomar Q-Yag 5 ND:Yag Laser System, Palomar Medical Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K143105: Picosure Workstation (2015), 49 descendants of its own
- K153527: PicoWay Laser System (2016), 41 descendants of its own
- K160607: PicoWay Laser System (2016), 34 descendants of its own
- K162454: PicoWay Laser System (2017), 33 descendants of its own
- K170597: PicoWay Laser System (2017), 32 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 Hemnostasis 1064 nm wavelength * Tattoo Removal (dark ink: blue and black) * Dermial Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, Melasma and Cafe-aui-jail * Removal or lightening of hair with or without adjuvant preparation. * Skin Resurfacing for Acne Scars and Wrinkles * Benign cutaneous lesions; including, 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, telangiectaslas, spider angioma, cherry angioma, spider nevi * Epidermal Pigmented lesions; including, but not limited to: cafe-au-hait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spiltis, sebonrheic keratosis * Skin Resurfacing for Acne Scars and Wrinkles * Benign cutaneous lesions; including, 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)

Source page: https://510kreport.com/device/K133254
Methodology: https://510kreport.com/methodology