# K253348: TargetCool-e

- Pathway: 510(k) (Traditional)
- Applicant: Recensmedical, Inc.
- Decided: Oct 15, 2025 after 15 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: 8 generations back to K991514 (1999). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230599: TargetCool™, Recensmedical, Inc. (2023) Summary page 5.

## Indications for use
TargetCool-e (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch). TargetCool-e (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures - Molluscum Contagiosum - Skin Tags - Actinic Keratosis - Lentigo - Verruca Plana - Verruca Vulgaris - Verruca Lesions - Genital Lesions - Seborrheic Keratosis

Source page: https://510kreport.com/device/K253348
Methodology: https://510kreport.com/methodology