# K123056: Pascal Laser Indirect Ophthalmoscope

- Pathway: 510(k) (Special)
- Applicant: Topcon Medical Laser Systems, Inc. (Tmls)
- Decided: Nov 13, 2012 after 43 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: 8 generations back to K894841 (1989). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062336: Optimedica Laser Indirect Ophthalmoscope, Optimedica Corporation (2006) Summary page 1.
- K111108: Pascal Streamline 577 (with Accessories), Topcon Medical Laser Systems, Inc. (2011) Summary page 2.

## Indications for use
The PASCAL® Laser Indirect Ophthalmoscope is intended for use with the PASCAL Streamline 577 laser or the PASCAL Streamline 532 laser when either of those lasers is used in the treatment of ocular pathology in the posterior segment; retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structural abnormalities of the retina and choroid including: 532nm macular edema age-related macular degeneration lattice degeneration retinal tears and detachments 577nm 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 retinopathy of prematurity Intended for use in the treatment of ocular pathology in the anterior segment including: 577nm iridotomy trabeculoplasty

Source page: https://510kreport.com/device/K123056
Methodology: https://510kreport.com/methodology