# K983673: Lasette

- Pathway: 510(k) (Traditional)
- Applicant: Cell Robotics, Inc.
- Decided: Jan 15, 1999 after 87 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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) Laser Lancet manufactured by TransMedica International: named in the summary without a submission number

## Most influential descendants
- K013021: Lightlance Laser Skin Perforator (2002), 2 descendants of its own
- K172818: LMT-3000 (2018), 1 descendant of its own
- K241646: Ortiv (Ortiv-BL, Ortiv-WH) (2024), 0 descendants of its own

## Indications for use
The Cell Robetic's Lasette Laser Skin Perforator is indicated for use for the perforation of skin to draw capillary blood for screening purposes.

Source page: https://510kreport.com/device/K983673
Methodology: https://510kreport.com/methodology