# K981746: Cell Robotics' Lasette

- Pathway: 510(k) (Traditional)
- Applicant: Cell Robotics, Inc.
- Decided: Dec 7, 1998 after 203 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) 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

## 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 Robotics Lasette Laser Skin Perforator is indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration, in both institutional and at-home settings.

Source page: https://510kreport.com/device/K981746
Methodology: https://510kreport.com/methodology