K-number	K251493
Device name	Skin Clinic Freeze Point for Warts and Skin Tags
Applicant	Cryoconcepts LP
Product code	GEH
Device class	Class II
Decision date	May 22, 2025
Decision	Substantially Equivalent
Regulation	878.4350

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Skin Clinic Freeze Point is an over-the-counter cryosurgical device intended for consumers to treat common warts, plantar warts, and skin tags. Skin tag treatment is restricted to adults age 22 years or older.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Skin Clinic Freeze Point for Warts and Skin Tags

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