# K992536: Technosanat Kryo TSK 2005

- Pathway: 510(k) (Traditional)
- Applicant: Technosanat Innovative Medizintechnik GmbH
- Decided: Oct 8, 1999 after 71 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) Palomar E2000 System: named in the summary without a submission number
- (no number) Laserscope Coolspot: named in the summary without a submission number
- (no number) Optimed Dermacool: named in the summary without a submission number
- (no number) Candela Dynamic cooling device: named in the summary without a submission number

## Indications for use
TECHNOSANAT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for: 1. The reduction of pain associated with laser treatment, 2. Less discomfort, 3. Cooling of the skin just before laser impulse treatment. Refer to the user manual for the laser to which the device is attached for cleared indications for use.

Source page: https://510kreport.com/device/K992536
Methodology: https://510kreport.com/methodology