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Ceralas Diode Laser System (Ceralas D15)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K964497

by Ceram Optec, Inc.

Identifiers

510(k) Number
K964497 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)

The Ceralas Diode Laser System (Ceralas D15) is a solid‑state surgical laser that uses a semiconductor diode to generate a near‑infrared treatment beam. It is intended for use in general and plastic surgery procedures and delivers laser energy through an optical fiber with an SMA 905 connector.

The system was cleared by the FDA through a traditional 510(k) pathway (K964497) as a Class 2 device, product code GEX, on 6 February 1997. It is supplied by Ceram Optec, Inc. in Washington, DC, and is identified as a reusable laser platform; no specific sterility or single‑use claims are stated in the available data.

Frequently asked questions

What types of surgeries is the Ceralas D15 intended for?

The device is indicated for general and plastic surgery procedures. Its near‑infrared beam is suitable for tissue cutting, coagulation, and remodeling tasks commonly performed in those specialties, providing clinicians with a versatile tool for a range of operative needs.

How is the laser energy delivered to the patient?

Energy is transmitted through an optical fiber equipped with an SMA 905 connector. This fiber‑optic delivery allows precise placement of the near‑infrared beam at the surgical site while keeping the main laser console separate from the operative field, enhancing safety and maneuverability.

Is the Ceralas D15 supplied sterile or as a reusable system?

The available data state that the Ceralas D15 is a reusable laser platform, and no specific sterility or single‑use claims are made. Users must follow standard aseptic protocols for any accessories that contact the patient, such as the fiber, to ensure appropriate infection control.

What regulatory pathway was used for the Ceralas D15’s clearance?

The system was cleared through the FDA’s traditional 510(k) pathway (K964497) as a Class 2 device, product code GEX. This means it was found substantially equivalent to a legally marketed predicate device, allowing it to be marketed in the United States after meeting the required safety and performance standards.

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: K964497 FDA 510(k) - CERALAS DIODE LASER SYSTEM (CERALAS D15), PDF 510(k) SUMMARY FOR CERAMOPTEC'S CERALAS DIODE LASER SYSTEMS (MODEL D15), CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 (K993911) — FDA 510 (k ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ceram Optec, Inc.

Sources (1)

  • FDA 510(k) K964497 24 fields · synced Sep 24, 2026