# K120622: Palomar Vectus Laser

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: May 23, 2012 after 83 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 K910422 (1992). 255 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053628: Lightsheer Duet Laser System, Lumenis, Inc. (2006) Summary page 1.
- K073300: Milesman Premium, Milesman S.L. (2007) Summary page 1.
- K100893: Cheveux Diode Laser System, Sandstone Medical Technologies, LLC (2010) Summary page 1.
- K110907: Palomar Icon (TM) Aesthetic System, Palomar Medical Technologies, Inc. (2011) Summary page 1.

## Most influential descendants
- K193426: Elite iQ (2020), 1 descendant of its own
- K162765: Venus Velocity Diode Laser System (2017), 1 descendant of its own
- K240396: Elite iQ PRO (M122K1) (2024), 0 descendants of its own
- K200786: Venus Epileve (2020), 0 descendants of its own

## Indications for use
The Palomar Vectus Laser is intended for all Fitzpatrick skin types, including tanned skin for use In aesthetic, dermatology, general and plastic surgery applications for the treatment of: The treatment of vascular lesions, such as angiomas, hemangiomas, telangiectasia and other benign vascular lesions. Treatment of leg veins. The treatment of benign pigmented lesions. Hair removal and permanent hair reduction. Treatment of pseudofolliculitis barbae. The SkinteT-M Reader is intended as an objective measurement tool for examining skin. melanin content for determining and setting a test spot starting fluence.

Source page: https://510kreport.com/device/K120622
Methodology: https://510kreport.com/methodology