Data / Medical devices / United States / Cryoconcepts LP
Cryoconcepts LP: FDA-registered device maker in Easton, PA, United States, 16 510(k) clearances
Cryoconcepts LP is registered with the FDA (registration 3008812068) in Easton, PA, United States. It lists 1 device type. The FDA files 16 510(k) clearances under its listings, the newest dated May 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008812068
- Address
- 1100 Conroy Place, Easton, PA, United States, 18040
- Owner or operator
- CryoConcepts LP (10034384)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- November 29, 2010
- Registered through
- 2026
- Brand names listed
- CryOmega, CryoClear, CryoLab Aesthetics, CryoLab Medical, Dr. Scholl's Freeze Away Skin Tag Remover, Dr. Scholl's Skin Tag Complete Care, Freezpoint, Histofreezer and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | 2 | Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 22, 2025 | K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | GEH | Substantially Equivalent | Cryoconcepts LP | accessdata.fda.gov |
| April 15, 2025 | K242932 | Skin Clinic Nitro Clear Wart Remover | GEH | Substantially Equivalent | Cryoconcepts LP | accessdata.fda.gov |
| October 25, 2024 | K242625 | Freeze Point & Private Label Versions | GEH | Substantially Equivalent | Cryoconcepts LP | accessdata.fda.gov |
| June 17, 2022 | K211099 | Freezen Clear Skin Clinic Warts & Tags | GEH | Substantially Equivalent | Cryoconcepts LP | accessdata.fda.gov |
| April 22, 2019 | K190407 | CryoLab | GEH | Substantially Equivalent | Cryoconcepts LP | accessdata.fda.gov |
| April 18, 2019 | K183601 | CryoTouch | GEH | Substantially Equivalent | Cryoconcepts LP | accessdata.fda.gov |
| October 6, 2010 | K102006 | CRYOMEGA | GEH | Substantially Equivalent | Stc Consulting, LLC | accessdata.fda.gov |
| March 20, 2003 | K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | GEH | Substantially Equivalent | OraSure Technologies, Inc. | accessdata.fda.gov |
| June 14, 1999 | K990877 | HISTOFREEZER DEVICE | GEH | Substantially Equivalent | OraSure Technologies, Inc. | accessdata.fda.gov |
| October 2, 1998 | K982358 | HISTOFREEZER DEVICE | GEH | Substantially Equivalent | OraSure Technologies, Inc. | accessdata.fda.gov |
| May 26, 1998 | K980739 | HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS | GEH | Substantially Equivalent | OraSure Technologies, Inc. | accessdata.fda.gov |
| October 21, 1997 | K971392 | HISTOFREEZER VERRUCA PLANA | GEH | Substantially Equivalent | OraSure Technologies, Inc. | accessdata.fda.gov |
| October 29, 1993 | K933327 | HISTOFREEZER | GEH | Substantially Equivalent | Solarcare, Inc. | accessdata.fda.gov |
| August 11, 1993 | K931299 | HISTOFREEZER | GEH | Substantially Equivalent | Solarcare Technologies Corp,Inc. | accessdata.fda.gov |
| February 5, 1993 | K924114 | HISTOFREEZER | GEH | Substantially Equivalent | Solarcare Technologies Corp,Inc. | accessdata.fda.gov |
| June 28, 1991 | K911420 | HISTOFREEZER | GEH | Substantially Equivalent | Solarcare Technologies Corp,Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.