# K091581: Supra 577.Y Laser

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Jun 16, 2009 after 14 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 K071687 (2008). 1 ancestor in all.
16 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071687: Famili of Iridex IQ Laser Systems, Iridex Corp (2008) Summary page 1.

## Most influential descendants
- K111108: Pascal Streamline 577 (with Accessories) (2011), 15 descendants of its own
- K121475: Txcell Scanning Laser Delivery System (2012), 6 descendants of its own
- K123542: Pascal Synthesis (532NM/577NM) Opthalmic Laser (2013), 5 descendants of its own
- K141851: Navilas Laser System (2015), 2 descendants of its own
- K223132: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) (2022), 1 descendant of its own

## Indications for use
The Supra 577.Y Laser system and accessories that are used with it to deliver laser energy in either CW pulse, MicroPulse or Long Pulse mode in the medical specialties of ophthalmology as follows: Ophthalmology: Indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina. and choroids. including: 1. Proliferative and nonproliferative diabetic retinopathy; 2. choroidal neovascularization; 3. branch retinal vein occlusion; 4. age-related macular degeneration; 5. retinal tears and detachments; 6. retinopathy of prematurity; Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma.

Source page: https://510kreport.com/device/K091581
Methodology: https://510kreport.com/methodology