# K110304: Apex ER. Yag / Ipl System

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Apr 8, 2011 after 65 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: 10 generations back to K910422 (1992). 111 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032599: Medical Laser Technologies, LLC MTL Erbium:Yag Laser System, Medical Laser Technologies, LLC (2003) Summary page 1.
- K081219: Apollo Mini Ipl System, Sandstone Medical Technologies, LLC (2008) Summary page 1.

## Most influential descendants
- K123777: Multilaser System (2013), 1 descendant of its own
- K233143: PiXel8-Reveal (2024), 0 descendants of its own

## Indications for use
The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery). The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter) Permanent hair reduction (650nm filter) Treatment of vascular lesions (Sl0nm filter) Treatment of benign pigmented lesions (510 nm filter) Mild to Moderate inflammatory acne (450nm filter)

Source page: https://510kreport.com/device/K110304
Methodology: https://510kreport.com/methodology