# K992298: Iriderm, Model Apex 800

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Dec 9, 1999 after 154 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: 3 generations back to K950019 (1995). 5 ancestors in all.
175 later devices descend from it; 1 cites it directly.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971737: Cynosure Photogenica Lpir Dermatological Laser, Cynosure, Inc. (1997) Summary page 1.
- K973324: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1997) Summary page 1.

## Most influential descendants
- K020849: Apex 800 Laser System, Model Apex 800 (2002), 174 descendants of its own
- K032846: Spectra Pulsed Diode Laser, Model DR-1 (2003), 173 descendants of its own
- K052848: Spectra Hair Removal Laser (2005), 172 descendants of its own
- K060839: Abc Hair Removal System (2006), 171 descendants of its own
- K053527: Spectra Hair Removal Laser (2008), 169 descendants of its own

## Indications for use
The IRIDERM Apex 800 is indicated for hair removal.

Source page: https://510kreport.com/device/K992298
Methodology: https://510kreport.com/methodology