# K962974: Sharplan Lasers, Inc. AF Acuspot Micromanipulator (713)

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Aug 21, 1996 after 21 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) Sharplan Model 712 Micromanipulator: named in the summary without a submission number
- (no number) Reliant UniMax Model 2000: named in the summary without a submission number
- (no number) Heraeus LaserSonics Ultraspot Micromanipulator: named in the summary without a submission number

## Indications for use
It is indicated for incision, excision, coagulation, ablation, and vaporization of soft tissue, to be used with compatible, legally marketed surgical lasers.

Source page: https://510kreport.com/device/K962974
Methodology: https://510kreport.com/methodology