# K980001: Jenascan

- Pathway: 510(k) (Traditional)
- Applicant: Jenoptik Laser, Optik, Systeme GmbH
- Decided: Mar 19, 1998 after 76 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) SofTouch Scanning Device (Sahar Technologies): named in the summary without a submission number
- (no number) Skinscan (Candela Corporation): named in the summary without a submission number
- (no number) SureScan (Clinicon Corporation): named in the summary without a submission number

## Most influential descendants
- K021650: Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser (2002), 0 descendants of its own

## Indications for use
The JENASCAN is intended for use as an accessory to surgical lasers, e.g., lasers used in dermatology and plastic surgery, for the ablation and vaporization of soft tissue under conditions of use as described in the manuals accompanying the lasers. Please refer to the application, operator’s, or user’s manual(s) accompanying the laser for professional use instructions and detailed use information concerning the laser.

Source page: https://510kreport.com/device/K980001
Methodology: https://510kreport.com/methodology