# K043486: Pascal Photocoagulator, Product-Pascal-01

- Pathway: 510(k) (Traditional)
- Applicant: Topcon Medical Laser Systems, Inc.
- Decided: Mar 3, 2005 after 76 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 K894841 (1989). 20 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 1.
- K972514: Laserex LP1532 Photocoagulator, Ellex Medical Pty, Ltd. (1997) Summary page 1.
- K020374: Oculight SL/SLX, Iridex Corp (2002) Summary page 1.
- K960971: Oculight GL, Iriderm Div. (1996) Summary page 1.
- K971950: Infinitech Multi-Spot Slit Lamp Laser Adapter, Infinitech, Inc. (1997) Summary page 1.

## Most influential descendants
- K091666: Pascal Photocoagulator, Pascal-US (2009), 23 descendants of its own
- K092621: Pascal Streamline Photocoagulator (2009), 22 descendants of its own
- K081744: Pascal Synthesis Delivery System (2008), 17 descendants of its own
- K100019: Pascal Streamline Photocoagulator (2010), 16 descendants of its own
- K111108: Pascal Streamline 577 (with Accessories) (2011), 15 descendants of its own

## Indications for use
The Pascal Photocoagulator indications for use are the following: Intended for use in the treatment of ocular pathology in both the posterior and anterior segments. Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: * proliferative and nonproliferative diabetic retinopathy * macular edema * choroidal neovascularization * branch and central retinal vein occlusion * age-related macular degeneration * lattice degeneration * retinal tears and detachments * Iridotomy, iridectomy and trabeculoplasty in angle closure and open angle glaucoma.

Source page: https://510kreport.com/device/K043486
Methodology: https://510kreport.com/methodology