# K960971: Oculight GL

- Pathway: 510(k) (Traditional)
- Applicant: Iriderm Div.
- Decided: Aug 28, 1996 after 170 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894841 (1989). 3 ancestors in all.
103 later devices descend from it; 5 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894841: Iris Oculight (TM) SL, Iriderm Div. (1989) Summary page 1.
- K913127: Coherent Novus 3000 Argon Photocoagulator, Coherent Medical Group (1991) Summary page 1.
- K932062: Ophthalas 532 Solid State Photocoagulator, Alcon Laboratories (1994) Summary page 1.

## Most influential descendants
- K020374: Oculight SL/SLX (2002), 69 descendants of its own
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories (2002), 65 descendants of its own
- K043486: Pascal Photocoagulator, Product-Pascal-01 (2005), 29 descendants of its own
- K091666: Pascal Photocoagulator, Pascal-US (2009), 23 descendants of its own
- K092621: Pascal Streamline Photocoagulator (2009), 22 descendants of its own

## Indications for use
The intended use of this device is retinal photocoagulation and laser trabeculoplasty to be performed by the ophthalmologist.

Source page: https://510kreport.com/device/K960971
Methodology: https://510kreport.com/methodology