# K081219: Apollo Mini Ipl System

- Pathway: 510(k) (Traditional)
- Applicant: Sandstone Medical Technologies, LLC
- Decided: Jun 30, 2008 after 61 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: 9 generations back to K910422 (1992). 105 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041829: Focus Medical Naturalase LP and Naturalight Family of Products, Focus Medical, LLC (2004) Summary page 1.
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K032191: Omnilight Fluorescent Pulsed Light System, Luxsano AB (2003) Summary page 1.

## Most influential descendants
- K110304: Apex ER. Yag / Ipl System (2011), 2 descendants of its own
- K123777: Multilaser System (2013), 1 descendant of its own
- K233143: PiXel8-Reveal (2024), 0 descendants of its own

## Indications for use
The Apollo Mini-IPL System is indicated for use 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 (51Onm filter) Treatment of benign pigmented lesions (51rOnm filter) Mild to Moderate inflammatory acne (450nm filter)

Source page: https://510kreport.com/device/K081219
Methodology: https://510kreport.com/methodology