# K960905: SDL Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Slt-J, Ltd.
- Decided: Jun 3, 1996 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: 1 generation back to K901365 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914197: Alloy Scalpel Handpieces, L.A.S.E.R., Inc. (1992) Summary page 2.
- K924120: Molded Fiber Cap Delivery System, Lca, Inc. (1993) Summary page 3.
- K924160: Hybrid Surgical Device, Lca, Inc. (1993) Summary page 3.
- K931070: Closed End Fiberoptic Laser Delivery System, Lca, Inc. (1993) Summary page 3.
- K932272: Closed End/Electrocautery Fiberopt Laser Deliv Sys, Lc Ent. (1993) Summary page 3.
- K901365: Laser Forceps Handpiece, Lca, Inc. (1990) Summary page 3.
- K914520: Diomed 25 Surgical Diode Laser, Urology Applicat, Dio-Med Corp. (1993) Summary page 3.
- K914521: Diomed 25 Surgical Diode Laser, Gen Surg Applicat, Dio-Med Corp. (1993) Summary page 3.
- K923991: Zoe Laser, Contact ND:Yag Laser System, Lca, Inc. (1993) Summary page 3.

## Cited in the summary but kept off the family tree
- K909128: ZOE Nd:YAG laser system. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 3.

Source page: https://510kreport.com/device/K960905
Methodology: https://510kreport.com/methodology