Identifiers
- 510(k) Number
- K872651 FDA 510(k)
- FDA Product Code
- FTC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4630 FDA 510(k)
- Regulation Number
- 878.4630 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Panosol 2000 624-414 is a Light, Ultraviolet, Dermatological device. It is substantially equivalent to other devices and is classified under the regulation number 878.4630. The device is used in the medical specialty of General and Plastic Surgery.
The device is supplied by National Biological Corp. and has been cleared under the FDA 510K authorization. It has a product code of FTC and is classified as a class 2 device. The device has a specific registration number and is used for dermatological purposes, with no additional information on its sterility, reusability, or MRI safety.
Frequently asked questions
What is the Panosol 2000 624-414 used for?
The Panosol 2000 624-414 is used for dermatological purposes in the medical specialty of General and Plastic Surgery.
Is the Panosol 2000 624-414 sterile?
There is no additional information on the sterility of the Panosol 2000 624-414.
What is the regulatory classification of the Panosol 2000 624-414?
The Panosol 2000 624-414 is classified as a class 2 device under regulation number 878.4630.
What is the product code of the Panosol 2000 624-414?
The product code of the Panosol 2000 624-414 is FTC.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PANOSOL 2000 624-414 (K872651) — FDA 510 (k) | Innolitics, PANOSOL 2000 624-414 510 (k) K872651 - FDA.report, K872706 FDA 510(k) - PANOSOL 2000 624-616, National Biological Corporation Products - medical-xprt.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K872651 | Class II | Active |
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Manufacturer
- Manufacturer
- National Biological Corp.
Sources (1)
- FDA 510(k) K872651 24 fields · synced Oct 6, 2026