# Cryoconcepts LP

- Location (FDA's records): Bethlehem, PA
- FDA decisions: 8 (2017–2025): 8 510(k) clearances
- Product codes: GEH (8)
- 510(k) review time since 2016: median 96 days, against 84 for FDA's reviews in the same codes and years (5 of 8 faster)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 10 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stc Consulting, LLC: 1 (https://510kreport.com/company/stc-consulting)
- Yonmedical BV: 1 (https://510kreport.com/company/yonmedical)
- OraSure Technologies, Inc.: 1 (https://510kreport.com/company/orasure-technologies)
- Solarcare, Inc.: 1 (https://510kreport.com/company/solarcare)
- Dgi Technologies: 1 (https://510kreport.com/company/dgi-technologies)
- Medtech Products, Inc.: 1 (https://510kreport.com/company/medtech-products)
- Nuance Medical, LLC: 1 (https://510kreport.com/company/nuance-medical)

## Firms that cite its devices most
- Recensmedical, Inc.: 2 (https://510kreport.com/company/recensmedical)
- Cryosurgery, Inc.: 2 (https://510kreport.com/company/cryosurgery)
- Medtech Products, Inc.: 1 (https://510kreport.com/company/medtech-products)
- Dgi Technologies: 1 (https://510kreport.com/company/dgi-technologies)
- Medical Brands Laboratories B.V.: 1 (https://510kreport.com/company/medical-brands-laboratories)
- Oystershell NV: 1 (https://510kreport.com/company/oystershell)

## Its most-cited devices
- K211099: Freeze’n Clear Skin Clinic Warts & Tags (2022), cited by 7
- K190407: CryoLab (2019), cited by 1
- K172769: CryOmega Flexx (2017), cited by 1
- K242932: Skin Clinic Nitro Clear Wart Remover (2025), cited by 1

## Recent decisions
- K251493: Skin Clinic Freeze Point for Warts and Skin Tags (May 22, 2025)
- K242932: Skin Clinic Nitro Clear Wart Remover (Apr 15, 2025)
- K242625: Freeze Point & Private Label Versions (Oct 25, 2024)
- K240106: Histofreezer V (Jun 10, 2024)
- K211099: Freeze’n Clear Skin Clinic Warts & Tags (Jun 17, 2022)
- K190407: CryoLab (Apr 22, 2019)
- K183601: CryoTouch (Apr 18, 2019)
- K172769: CryOmega Flexx (Nov 30, 2017)

Source page: https://510kreport.com/company/cryoconcepts