# Nuance Medical, LLC

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 6 (2013–2024): 6 510(k) clearances
- Product codes: GEH (3), MLY (3)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 8 (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
- Gebauer Co.: 2 (https://510kreport.com/company/gebauer)
- Cryosurgery, Inc.: 2 (https://510kreport.com/company/cryosurgery)
- OraSure Technologies, Inc.: 1 (https://510kreport.com/company/orasure-technologies)
- Cryosurg, Inc.: 1 (https://510kreport.com/company/cryosurg)

## Firms that cite its devices most
- Cryosurgery, Inc.: 3 (https://510kreport.com/company/cryosurgery)
- Cryoconcepts LP: 1 (https://510kreport.com/company/cryoconcepts)
- Cool Renewal, LLC: 1 (https://510kreport.com/company/cool-renewal)
- Gebauer Co.: 1 (https://510kreport.com/company/gebauer)

## Its most-cited devices
- K130995: Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray (2013), cited by 4
- K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 (2016), cited by 2
- K161337: CryoDose H or Similar (2016), cited by 1
- K232674: PainFreeze II (2024), cited by 1

## Recent decisions
- K232674: PainFreeze II (Feb 12, 2024)
- K210310: CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit (Oct 22, 2021)
- K172203: CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray (Oct 18, 2017)
- K162218: Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102 (Nov 22, 2016)
- K161337: CryoDose H or Similar (Jul 12, 2016)
- K130995: Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray (Jun 14, 2013)

Source page: https://510kreport.com/company/nuance-medical