# K962948: Ceralas G ND;Yag Laser System (Ceralas G)

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Oct 25, 1996 after 88 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
No predicates in its family tree.
19 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Biovision Crystal Emerald Focus: named in the summary without a submission number
- (no number) Zeiss Diode Pumped Solid State Laser: named in the summary without a submission number
- (no number) Coherent Innova Argon and Coherent Series 599 Dye Laser: named in the summary without a submission number
- (no number) HGM Compac 110 Argon Laser: named in the summary without a submission number

## Most influential descendants
- K980547: Nidek Prima Model Gyc-1500/2000 (1998), 18 descendants of its own
- K032085: Green Laser Photocoagulator Model Gyc-1000 (2003), 17 descendants of its own
- K042785: Multi Color Laser Photocoagulator, Model MC-300 (2004), 15 descendants of its own
- K110228: Nidek Multicolor Laser Photocoagulator (2011), 9 descendants of its own
- K152603: Green Laser Photocoagulator GYC-500 (2016), 6 descendants of its own

## Indications for use
The Ceralas G is intended to be used as a surgical instrument for photocoagulation of ocular tissue as well as ablation of tissue of the iris and trabeculum. It is already cleared for photocoagulation of retinal tissue.

Source page: https://510kreport.com/device/K962948
Methodology: https://510kreport.com/methodology