# K013760: DC-3300 Laser Diode Photocoagulator

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Feb 11, 2002 after 90 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 K903639 (1991). 2 ancestors in all.
70 later devices descend from it; 4 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903639: Nidek DC-3000 Diode Laser Photocoagulator, Nidek, Inc. (1991) Summary page 1.
- K913430: Iris Oculight (R) SLX, Iriderm Div. (1991) Summary page 1.

## Most influential descendants
- K020374: Oculight SL/SLX (2002), 69 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
- K031665: Iris Medical Oculight GL/GLX Laser Systems (2003), 21 descendants of its own

## Indications for use
The Nidek DC-3300 Laser Diode Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The DC-3300 is used in combination with various delivery systems, such as slit lamps, binocular indirect ophthalmoscopes, endoprobes, and transscleral probes.

Source page: https://510kreport.com/device/K013760
Methodology: https://510kreport.com/methodology