# K061850: Mini-Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: American Lasers, Inc.
- Decided: Sep 29, 2006 after 91 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: 4 generations back to K950019 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023967: Palomar Q-Yag ND:Yag Laser System, Palomar Medical Technologies, Inc. (2003)
- K022709: Medlite Q-Swithced Laser, Continuum Electro-Optics, Inc. (2003) Summary page 1.
- K983054: Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser, Continuum Biomedical, Inc. (1999) Summary page 1.
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001) Summary page 1.
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 1.
- K000317: Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM, Tissue Medical Lasers, Inc. (2000). Our reading of the summary gave K100317, FDA’s number for Digital X-Ray Imaging System (Pax-Primo) Model Pax-Primo (VATECH Co., Ltd.), decided Mar 24, 2010, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Spectra-VXM Q-Switched Nd:YAG Laser”.

## Cited in the summary but kept off the family tree
- K033259: Light Age Q-Clear Laser, Model 701-1101, Light Age, Inc. (2004). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
American Lasers Inc.'s a solid-state Nd:YAG laser system that provides two wavelengths, 1064nm and 532nm for the removal of black and blue tattoos as well as superficial epidermal pigmented lesions and small vascular lesions. Tattoos removal: The 532nm wavelength can be used to remove red, tan, purple, and orange tattoo inks. The 1064nm wavelength can be used to remove dark (black) and blue color inks. The 532nm wavelength can also be used for removal of superficial benign, pigmented skin lesions such as lentigines and cafe-au-lait, treatment of common nevi, and seborrheic keratoses. Also the 532nm wavelength can be used to remove small vascular lesions such as telangiectasias, small facial and leg veins, angiomas, hemangiomas, port-wine stains, and most other benign pigmented lesions such as lentigines and ephelides. The 1064nm wavelength can also be used to treat pigmented lesions such as the nevus of Ota, removal or lightening of hair, treatment of common nevi.

Source page: https://510kreport.com/device/K061850
Methodology: https://510kreport.com/methodology