# K971216: Frigiderm Frigispray

- Pathway: 510(k) (Traditional)
- Applicant: Dermatologic Lab & Supply, Inc.
- Decided: May 29, 1997 after 57 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
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) Brymill Cryogun: named in the summary without a submission number

## Indications for use
This product is intended to be used by Dermatologists and/or Plastic Surgeons for the following procedures. Freeze destruction on epithelial arising cryoresponsive benign, premalignant and malignant tumors, such as skin tags, verrucae, cutaneous homs, actinic keratoses, and basal cell carcinoma.

Source page: https://510kreport.com/device/K971216
Methodology: https://510kreport.com/methodology