# K970995: CMS Cryolite

- Pathway: 510(k) (Traditional)
- Applicant: Cryomedical Sciences, Inc.
- Decided: Jul 7, 1997 after 110 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K840536 (1984). 1 ancestor in all.
37 later devices descend from it; 3 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840536: Cryo Surg 5900, Frigitronics of Connecticut, Inc. (1984) Summary page 1.
- (no number) Frigitronics Cryocare I: named in the summary without a submission number
- (no number) Cryomedics Model MT700: named in the summary without a submission number

## Most influential descendants
- K072883: Ice-Sense (2007), 26 descendants of its own
- K102360: Icesence 3 (2010), 25 descendants of its own
- K133258: Trufreeze System (2014), 20 descendants of its own
- K143625: truFreeze System (2015), 19 descendants of its own
- K040809: Crymed Cryo-Ablator (2004), 16 descendants of its own

## Indications for use
The CMS Cryo-lite® System has the same indications for use as its predicate devices, the Frigitronics Model 5900, Frigitronics Cryocare I and the Cryomedics Model MT700. The Cryo-lite® System is intended to be used as a cryosurgical tool for destruction of unwanted tissug itr the fields of dermatology, ‘gynecology general surgery, etc. and veterinary medicine.

Source page: https://510kreport.com/device/K970995
Methodology: https://510kreport.com/methodology