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Pain Freeze™, Medium Stream Spray, Model #2101 +1 more model
FDA 510(k)U (US FDA 510(k))
510(k) K162218
Identifiers
- 510(k) Number
- K162218 FDA 510(k)
- FDA Product Code
- MLY FDA 510(k)
- Models / Variants
- Pain Freeze™, Mist Spray, Model #2102 FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Pain Freeze™, Medium Stream Spray, Model #2101 +1 more model by Nuance Medical, Llc — U — FDA_510K — listed in FDA 510(k) — 2 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162218 | U | Active |
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Manufacturer
- Manufacturer
- Nuance Medical, Llc
Sources (1)
- FDA 510(k) K162218 24 fields · synced Jun 18, 2026