Identifiers
- 510(k) Number
- K923953 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)
Megabeam is a medical device identified by the FDA as substantially equivalent to a predicate device, cleared through a traditional 510(k) submission. The device is listed under product code GEX and was reviewed by the General Plastic Surgery advisory committee.
The clearance was issued on 1992-11-17 following a submission received on 1992-08-06. Megabeam is manufactured by Ceram Optec, Inc., located in Washington, DC, United States, and is identified by K-number K923953.
Frequently asked questions
What is the Megabeam device used for?
The Megabeam device is used for general plastic surgery purposes, as identified by the FDA under product code GEX.
How was the Megabeam device cleared by the FDA?
The Megabeam device was cleared through a traditional 510(k) submission, which determined it to be substantially equivalent to a predicate device.
What is the K-number for the Megabeam device?
The K-number for the Megabeam device is K923953, which was issued on November 17, 1992, following a submission received on August 6, 1992.
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: K952340 - MEGABEAM ASPIRATING ENDOCULAR PROBE | FDA 510(k), Optical Fibers & OEM Fiber Assemblies | CeramOptec, K943445 FDA 510 (k) - MEGABEAM FIBER OPTIC DELIVERY SYSTEM, Optical Fiber Solutions & OEM Assemblies | CeramOptec, Ceram Optec Inc FDA Filings
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923953 | Class II | Active |
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Manufacturer
- Manufacturer
- Ceram Optec, Inc.
Sources (1)
- FDA 510(k) K923953 24 fields · synced Sep 26, 2026