# K965124: Lasette

- Pathway: 510(k) (Traditional)
- Applicant: Cell Robotics, Inc.
- Decided: Aug 14, 1997 after 234 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) commercially available blood lancet devices: named in the summary without a submission number
- (no number) commercially available solid state laser devices for dermatological surgery: named in the summary without a submission number

## Indications for use
The Cell Robotics Lasette is indicated for use by qualified healthcare workers for perforation of the skin to draw capillary bleod from healthy adult patients for subsequent determination of blood glucose concentration and hematocrit using colorimetric measurements.

Source page: https://510kreport.com/device/K965124
Methodology: https://510kreport.com/methodology