Identifiers
- 510(k) Number
- K134040 FDA 510(k)
- FDA Product Code
- OLI FDA 510(k)
- Models / Variants
- Btl-9000 FDA 510(k)Btl-9000 Radiofrequency Module FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5400 FDA 510(k)
- Regulation Number
- 878.5400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Btl-9000 +1 more model by BTL Industries, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 2 models — 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 | K134040 | Class II | Active |
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Manufacturer
- Manufacturer
- BTL Industries, Inc.
- FDA Applicant
- Btl Industries, Ltd.
Sources (1)
- FDA 510(k) K134040 24 fields · synced Jun 19, 2026