# K981126: Ceralas G Frequency Doubled ND: Yag Laser Systems, Ceralas G3

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Jun 25, 1998 after 90 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
Longest line of descent: 3 generations back to K933880 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954834: Ceralas G Frequency Doubled ND;Yag Laser System, Ceram Optec, Inc. (1996) Summary page 1.
- K923953: Megabeam, Ceram Optec, Inc. (1992) Summary page 1.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 1.
- K951775: Ceralas Diode Laser System (Model Ceralas D50), Ceram Optec, Inc. (1995) Summary page 1.
- K964074: Diolite 532, Iriderm Div. (1997) Summary page 1.
- K954905: CB Diode/532 Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.

## Indications for use
The Ceralas G Frequency Doubled Nd:YAG Laser System and Accessories is intended as a surgical instrument for use in the photocoagulation of: 1) ocular tissue, and 2) vascular and pigmented skin lesions.

Source page: https://510kreport.com/device/K981126
Methodology: https://510kreport.com/methodology