# K982230: Lasette Laser Skin Perforator

- Pathway: 510(k) (Traditional)
- Applicant: Cell Robotics, Inc.
- Decided: Sep 24, 1998 after 177 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) Glucolet Steel Lancet: named in the summary without a submission number
- (no number) Feather-Touch Steel Lancet: named in the summary without a submission number
- (no number) Tenderlett Steel lances: named in the summary without a submission number
- (no number) TriLase 2940: named in the summary without a submission number
- (no number) Medlite: named in the summary without a submission number
- (no number) Protégé: named in the summary without a submission number

## Indications for use
The Cell Robotic's Lasette Laser Skin Perforator is indicated for use by qualified healthcare professionals for collecting capillary blood samples from adult patients for subsequent determination of blood glucose concentration and hematocrit.

Source page: https://510kreport.com/device/K982230
Methodology: https://510kreport.com/methodology