# K983463: Surecaut Diamond Laser Knife

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Dec 11, 1998 after 71 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 K863086 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863086: Sapphire Laser Blades (Laser Blades) ND: Yag, Cooper Lasersonics, Inc. (1986) Summary page 1.

## Indications for use
The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures.

Source page: https://510kreport.com/device/K983463
Methodology: https://510kreport.com/methodology