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Boucher Degroot Head Positioning Glasses, Model 8080
FDA 510(k)Class I (US FDA 510(k))
510(k) K000544
Identifiers
- 510(k) Number
- K000544 FDA 510(k)
- FDA Product Code
- HJX FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5810 FDA 510(k)
- Regulation Number
- 886.5810 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Boucher Degroot Head Positioning Glasses, Model 8080 by Labtician Ophthalmics, Inc — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
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 | K000544 | Class I | Active |
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Manufacturer
- Manufacturer
- Labtician Ophthalmics, Inc
- FDA Applicant
- Labtician Ophthalmics, Inc.
Sources (1)
- FDA 510(k) K000544 24 fields · synced Jun 18, 2026