# K062369: Iridex Oculight TX

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Nov 8, 2006 after 86 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: 8 generations back to K910422 (1992). 98 ancestors in all.
73 later devices descend from it; 1 cites it directly.
0 of 172 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050562: Oculight GL/GLX, Iridex Corp (2005) Summary page 1.
- K022327: Novus Spectra, Lumenis, Inc. (2002) Summary page 1.
- K032220: Adept 1064/532 Laser, Adept Medical Concepts (2003) Summary page 1.
- K002296: Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15, Ceram Optec, Inc. (2000) Summary page 1.

## Most influential descendants
- K091534: Lightlas Model 532 (2009), 72 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (2010), 46 descendants of its own
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (2011), 26 descendants of its own
- K120810: Fiberoptic Laser Delivery System (2012), 24 descendants of its own

## Indications for use
The OcuLight TX is intended to be used in ENT surgery for tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis. Indications for use include, but are not limited to: Stapedectomy, Stapedotomy Myringotomy Lysis of adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic Procedures The OcuLight TX is intended to photocoagulate issue in dermatological procedures. Indications for use include: Focal laser treatment of vascular and pigmented skin lesions. The OcuLight TX is intended to photocoagulate ocular tissue in ophthalmic procedures. Indications for use include: Retinal Photocoagulation Laser Trabeculoplasty Iridotomy Iridoplasty

Source page: https://510kreport.com/device/K062369
Methodology: https://510kreport.com/methodology