# K032667: Focus Medical 532 Hand Piece Adapter and Dye Pack Accessories (Red or Yellow)

- Pathway: 510(k) (Traditional)
- Applicant: Focus Medical, LLC
- Decided: Jan 23, 2004 after 148 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: 1 generation back to K011677 (2001). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001)
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 1.

## Most influential descendants
- K170850: Alma Q (2017), 2 descendants of its own
- K233024: Alma Harmony (2024), 1 descendant of its own
- K252561: BTL-754FF (2026), 0 descendants of its own

## Indications for use
The 532 Hand Piece Adapter and the Dye Pack Accessories (Red or Yellow), when attached to the NaturaLase 1064 Laser, are indicated for: Tattoo removal Red inks (532 nm Hand Piece Adapter) Blue and light blue inks (Yellow Dye Pack) Green inks (Red Dye Pack) Treatment of Vascular Lesions - Using the 532 nm Hand Piece Adapter Port wine birthmark Telangiectasias Spider angiomas Cherry angiomas Spider nevi Treatment of Pigmented Lesions - Using the 532 nm Hand Piece Adapter Café-au-lait birthmarks Solar lentigines Senile lentigines Becker's nevi Freckles Nevus spilus Nevus of ota Incision, excision, ablation, and vaporization of soft tissue in dermatology - Using the 532 Hand Piece Adapter.

Source page: https://510kreport.com/device/K032667
Methodology: https://510kreport.com/methodology