Histofreezer
FDA 510(k) K933327 · Solarcare, Inc.
510(k) numberK933327
Submission
- Device name
- Histofreezer
- Applicant
- Solarcare, Inc.
Bethlehem, PA, US - Received
- July 8, 1993
- Decision date
- October 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K261806 | ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special | Erbe Elektromedizin GmbH | 06/09/2026SE |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional | Erbe Elektromedizin GmbH | 04/22/2026SE |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional | Medical Brands Laboratories B.V. | 04/02/2026SE |
| K260377 | XSense Cryoablation System with CryoProbesGEH · Special | IceCure Medical , Ltd. | 02/24/2026SE |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional | Medinice S.A. | 02/13/2026SE |
| K251524 | Dr. Yglo Skin Tag RemoverGEH · Traditional | Theotclab Healthcare B.V. | 01/12/2026SE |
| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K934775 | STC Cocaine Metabolite EiaDIO · Traditional | 07/14/1995SE |
| K944372 | STC Diagnostic Auto-Lyte Propoxyphene EiaJXN · Traditional | 02/08/1995SE |
| K941496 | Solarcare Total Protein Micro-Plate AssayCEK · Traditional | 10/27/1994SE |
| K941497 | Solarcare Alanine Aminotransferase Micro-Plate AssayCKA · Traditional | 05/24/1994SE |
| K934376 | STC Diagnostics Auto-Lyte Barbiturates EiaDIS · Traditional | 12/07/1993SE |
Questions and answers
When was Histofreezer cleared by the FDA?
Histofreezer (K933327) received a 510(k) decision of Substantially Equivalent on October 29, 1993, 113 days after the submission was received.
What is the product code of K933327?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.