FreezeSpray TA— 510(k) K261684

Name: FDA 510(k) clearance K261684
Creator: U.S. Food and Drug Administration
Published: 2026-09-05

Substantially Equivalent

Cryosurgery, Inc.

FDA 510(k) clearance K261684 for FreezeSpray TA, Substantially Equivalent on 2026-09-05. Applicant: Cryosurgery, Inc.. Device class: Unclassified.

Summary

FreezeSpray TA from Cryosurgery is filed under MLY, vapocoolant devices. The record doesn't say what "TA" stands for.

The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The Physical Medicine review panel handled it as a Traditional 510(k).

Cryosurgery filed from Nashville, Tennessee. Review took 107 calendar days (May 21 to September 5, 2026).

Clearance details

Applicant: Cryosurgery, Inc.
Product code: Product code MLY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2026-05-21
Decision date: 2026-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

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K202782 — num Vapocoolant2020-12-21

More clearances from Cryosurgery, Inc.

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K253000 — CryoFreeze Wart and Skin Tag Remover2025-10-16
K252903 — Verruca-Freeze H Plus2025-10-10
K243487 — CryoFreeze Wart and Skin Tag Remover2025-03-13
K243454 — Verruca-Freeze H2024-12-03
K233347 — Verruca-Freeze® H2023-12-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.