# K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor

- Pathway: 510(k) (Special)
- Applicant: Hoya Photonics, Inc.
- Decided: Nov 19, 2010 after 29 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 249 ancestors in all.
92 later devices descend from it; 3 cite it directly.
0 of 342 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083899: Revlite Q-Switched ND:Yag Laser System, Hoya Conbio, Inc. (2009) Summary page 1.

## Most influential descendants
- K121346: Picosure Workstation (2012), 87 descendants of its own
- K142372: Pico Way Laser System (2014), 70 descendants of its own
- K150326: PicoWay Laser System (2015), 68 descendants of its own
- K133254: Revlite Q-Switched ND:Yag Laser System (2014), 57 descendants of its own
- K133364: Picosure Workstation (2014), 51 descendants of its own

## Recalls of this device
- May 9, 2013 · Class II · Z-1599-2013: An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.

## Indications for use
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. 1064 nm wavelength Tattoo Removal (dark ink: blue and black) Dermal Pigmented Lesions 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 nim 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 (excludes the 650nm wavelength)

Source page: https://510kreport.com/device/K103118
Methodology: https://510kreport.com/methodology