Medicam 900 Autoelectronic Light Source

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K922544 ↗

FDA Product Code

FST

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Is the Medicam 900 Autoelectronic Light Source intended for single-use or reusable in clinical settings?

  The Medicam 900 Autoelectronic Light Source is designed as a reusable medical device, as explicitly stated in the regulatory data. Since it is classified under FDA regulation 878.4580 and lacks any mention of sterility specifications or single-use requirements, it is meant for repeated use in controlled surgical environments after proper cleaning and maintenance.

• What types of surgical procedures is the Medicam 900 Autoelectronic Light Source primarily used for?

  The device is intended for general and plastic surgery procedures, as indicated by its advisory committee classification (SU) and the medical specialty description in the regulatory data. It provides focused illumination via fiberoptic technology to enhance visibility during operative procedures.

• How is the Medicam 900 Autoelectronic Light Source regulated in the U.S.?

  The Medicam 900 received FDA 510(k) clearance (K922544) in 1992 under the Substantially Equivalent (SESE) determination, meaning it was deemed comparable to a legally marketed predicate device. It falls under FDA regulation 878.4580 and is classified as a Class II device (as noted in OpenFDA data). No MRI safety or sterility specifications are explicitly mentioned in the available regulatory records.

• Are there different models or sizes available for the Medicam 900 Autoelectronic Light Source?

  The provided regulatory data does not specify distinct models or sizes for the Medicam 900 Autoelectronic Light Source. However, the product code (FST) and multiple registration numbers suggest it may be distributed under various lot or batch identifiers. For exact configurations, consulting the manufacturer’s catalog or technical documentation would be necessary.

• What should clinicians consider regarding storage and maintenance of the Medicam 900 Autoelectronic Light Source?

  Since the device is reusable, proper cleaning, sterilization, and maintenance are critical to ensure functionality and safety. The regulatory data does not detail storage conditions, but as a surgical fiberoptic light source, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for reprocessing to prevent damage to the fiberoptic components.