CERMAX300 LIGHTSOURCE

K981469 · Cuda Products Co. · FSS · Jul 9, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981469
• Device Name: CERMAX300 LIGHTSOURCE
• Applicant: Cuda Products Co.
• Product Code: FSS · General, Plastic Surgery
• Decision Date: Jul 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: Ilightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.

Device Story

Cermax300 is a lightsource/illuminator designed for surgical environments. Device functions by generating high-intensity light, transmitted through fiberoptic cables to connected surgical instruments, specifically headlights or endoscopes. Operated by surgeons or clinical staff in surgical fields to provide necessary visualization. Device serves as a power source for optical instrumentation; facilitates surgical procedures by ensuring adequate illumination of the operative site. No complex processing or AI/ML components involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Lightsource/illuminator unit. Provides illumination via fiberoptic cable interface. Designed for connection to standard surgical headlights and endoscopes. Class II device.

Indications for Use

Indicated for providing illumination to surgical fields via fiberoptic cables connected to surgical instruments such as headlights or endoscopes. Intended for prescription use in clinical/surgical settings.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

વે 1698 . III II

Ms. Kim Reed · Director of Advertising and Marketing Cuda Products Corporation 6000 Powers Avenue Jacksonville, Florida 32217

Re: K981469 Trade Name: Cermax300 Lightsource Regulatory Class: II Product Code: FSS Dated: April 21, 1998 Received: April 23, 1998

Dear Ms. Reed:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Ms. Kim Reed

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin McWhirter, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

K9811469

Device Name:

Lightsource or illuminator CERMAX300

Indications for use:

To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: Ilightsource attaches to fiberoptic cable which is then attached to a headlight or Endoscope. The lightsource supplies light for the headlight or Endoscope.

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Over-The-Counter USE _________________________________________________________________________________________________________________________________________________________ Prescription USE or (Optional format 1-2-96) (Division Sign-Off Divisior It General Reston જ્ઞાન 69 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lightsource or illu
CERMAX300