# K960086: DCL8 Enhanced  Pulsed ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Slt-J, Ltd.
- Decided: Jun 3, 1996 after 144 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.
No later device cites it as a predicate yet.
0 of 1 device 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) SunLase Master Pulsed Nd:YAG laser system: named in the summary without a submission number
- (no number) SunLase Pulsed Nd:YAG laser system: named in the summary without a submission number
- (no number) PulseMaster 600 Pulsed Nd:YAG laser system: named in the summary without a submission number
- (no number) PulseMaster 1000 Pulsed Nd:YAG laser system: named in the summary without a submission number

## Indications for use
for use in procedures for incision, excision, coagulation or vaporization of soft tissues, such as, but not limited to: subcutaneous tissues, striated and smooth muscle, mucous membranes, along with organs and glands, in both open, endoscopic and laparoscopic procedures.

Source page: https://510kreport.com/device/K960086
Methodology: https://510kreport.com/methodology