# K033799: Clinical Lasette P-200

- Pathway: 510(k) (Special)
- Applicant: Cell Robotics, Inc.
- Decided: Dec 22, 2003 after 17 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) Cell Robotics, Inc. Lasette Plus: named in the summary without a submission number

## Indications for use
The Cell Robotic's Clinical Lasette P-200 Laser Skin Perforator is indicated for use by qualified healthcare professionals for the perforation of skin to draw capillary blood for screening purposes.

Source page: https://510kreport.com/device/K033799
Methodology: https://510kreport.com/methodology