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Cutera Er:yag Laser Handpiece
FDA 510(k)Class II (US FDA 510(k))
510(k) K070138
by Cutera, Inc.
Identifiers
- 510(k) Number
- K070138 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
A comprehensive 2-3 paragraph SEO description written in clear, natural language. The device provides precise and efficient cutting of tissue, allowing for accurate diagnoses and effective treatments.
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 | K070138 | Class II | Active |
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Manufacturer
- Manufacturer
- Cutera, Inc.
Sources (1)
- FDA 510(k) K070138 24 fields · synced Jul 24, 2026