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Varios 170 Lux Scaler System (va170luxs10) +2 more models
FDA 510(k)Class II (US FDA 510(k))
510(k) K251689
Identifiers
- 510(k) Number
- K251689 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
- Models / Variants
- Varios 170 Lux Scaler System (va170luxs10) FDA 510(k)Varios 170 Lux Scaler System (va170luxs11) FDA 510(k)Varios 170 Scaler System (va170s11) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Varios 170 Lux Scaler System (va170luxs10) +2 more models by Nakanishi Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 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 | K251689 | Class II | Active |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
- FDA Applicant
- Nakanishi, Inc.
Sources (1)
- FDA 510(k) K251689 24 fields · synced Jun 18, 2026