# K020849: Apex 800 Laser System, Model Apex 800

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: May 20, 2002 after 66 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). 10 ancestors in all.
174 later devices descend from it; 3 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992298: Iriderm, Model Apex 800, Iridex Corp (1999) Summary page 1.
- K003614: Lightsheer Pulsed Diode Array Laser System, Coherent Star (2001) Summary page 1.
- K992757: Cynosure Apogee-TKS Dermatological Laser, Cynosure, Inc. (2000) Summary page 1.
- K010005: Cynosure Photogenica DL, Cynosure, Inc. (2001) Summary page 1.
- K013028: Palomar SLP 1000, Palomar Medical Products, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K072906: SILK'N (2008), 169 descendants of its own

## Indications for use
The IRIDEX® Apex 800 Laser System is indicated for hair removal and permanent hair reduction on all skin types (Fitzpatrick skin types I-VI), including tanned skin; for the treatment of pseudofolliculitis barbae; for the treatment of vascular lesions including angiomas, hemangiomas, telangiectasia; for the treatment of leg veins; and for the treatment of benign pigmented lesions.

Source page: https://510kreport.com/device/K020849
Methodology: https://510kreport.com/methodology