# K193619: Cry-Ac®, Cry-Ac-3®, Cry-Baby

- Pathway: 510(k) (Traditional)
- Applicant: Brymill Cryogenic Systems
- Decided: Mar 25, 2020 after 90 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: 4 generations back to K010991 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031117: Seednet System and Seednetgold System, Galil Medical, Ltd. (2003) Summary page 4.
- K982280: Cryopro Maxi and Cryopro Mini, Cortex Technology Aps (1998) Summary page 4.
- K935010: Wallach Ultra Freeze, Wallach Surgical Devices, Inc. (1994) Summary page 4.
- (no number) Cry-Ac B-700 and B-800 and Accessories: named in the summary without a submission number

## Indications for use
The Cry-Ac® Cryosurgical Devices and Accessories are intended for use as cryosurgical tools in the field of dermatology. The Cry-Ac® Cryosurgical Devices and Accessories are indicated for: Ablation or freezing of skin cancers and other cutaneous disorders Destruction of skin tags, warts or lesions, angiomas, sebaceous hyperplasia, basal cell carcinoma, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin

Source page: https://510kreport.com/device/K193619
Methodology: https://510kreport.com/methodology