# K983950: Ceralas Diode Laser System (Model H)

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Feb 3, 1999 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 K950019 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974346: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1998) Summary page 1.
- K973324: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1997) Summary page 1.

## Indications for use
The Ceralas H ROBnm Dicde Laser System is indicated to treat les veins in darmatologv and plastic swrgery procedures.

Source page: https://510kreport.com/device/K983950
Methodology: https://510kreport.com/methodology