# K964751: Ceralas Diode Laser System (Ceralas D2)

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Feb 21, 1997 after 87 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Iris Medical Oculight SLx: named in the summary without a submission number
- (no number) Keeler Microlase SL: named in the summary without a submission number
- (no number) Nidek DC3000: named in the summary without a submission number

## Most influential descendants
- K061025: Accutech Endolite Probe (2006), 1 descendant of its own
- K090281: Accutech Family of Powerflex Laser Delivery Devices (2009), 0 descendants of its own

## Indications for use
The Ceralas D2 and the predicates have the same intended use; photocoagulation of ocular tissue.

Source page: https://510kreport.com/device/K964751
Methodology: https://510kreport.com/methodology