# K971950: Infinitech Multi-Spot Slit Lamp Laser Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Infinitech, Inc.
- Decided: Aug 1, 1997 after 65 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 K844357 (1985). 1 ancestor in all.
30 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K844357: System 920 Argon/Dye Photocoagulator, Coherent Medical Group (1985) Summary page 2.
- (no number) Alcon/Biophysic Ophthalas: named in the summary without a submission number
- (no number) Alcon Ophthlas 532 Laser: named in the summary without a submission number

## Most influential descendants
- 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
- K081744: Pascal Synthesis Delivery System (2008), 17 descendants of its own
- K100019: Pascal Streamline Photocoagulator (2010), 16 descendants of its own

## Indications for use
The Multi-Spot Slit Lamp Laser Adapter has two functional modes available to the physician: a single spot mode and a Multi-Spot (4 spot) mode. When the single spot mode is selected, the preexisting slit lamp laser apparatus is available for all treatment functions for which it was designed as a laser photocoagulator. The multi-spot mode is intended for use with "Green-Only" (514-532nm) laser energy for panretinal photocoagulation in the treatment of proliferative retinopathy.

Source page: https://510kreport.com/device/K971950
Methodology: https://510kreport.com/methodology