Dr. Scholl's Dual Action Freeze Away Wart Remover, Model 40406
FDA 510(k) K052259 · Schering-Plough Healthcare Products, Inc.
510(k) numberK052259
Submission
- Device name
- Dr. Scholl's Dual Action Freeze Away Wart Remover, Model 40406
- Applicant
- Schering-Plough Healthcare Products, Inc.
Berkeley Heights, NJ, US - Received
- August 19, 2005
- Decision date
- December 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
More from Recensmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K031697 | Dr. Scholl's Freeze Away Wart Remover, Model 40226GEH · Traditional | 08/29/2003SE |
Questions and answers
When was Dr. Scholl's Dual Action Freeze Away Wart Remover, Model 40406 cleared by the FDA?
Dr. Scholl's Dual Action Freeze Away Wart Remover, Model 40406 (K052259) received a 510(k) decision of Substantially Equivalent on December 14, 2005, 117 days after the submission was received.
What is the product code of K052259?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.