Intended for light activation of bleaching materials for teeth whitening. Note: This is an additional indication to the already cleared indications for use.

Device Description

The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System, which has already been cleared by FDA. The cleared Ceralas D Laser System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaALAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode: (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFIshielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635mm+10mm. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.

AI/ML Overview

The provided text describes a 510(k) submission for the Ceralas Diode Laser System, seeking to add an indication for light activation of bleaching materials for tooth whitening. The submission focuses on demonstrating substantial equivalence to a predicate device for this specific intended use.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance for light activation of bleaching materials for teeth whitening (implicitly, similar effectiveness to predicate device).	Bench studies demonstrated that the Ceralas D 980nm Laser System performed similarly to the PAC light for light activation of bleaching materials for teeth whitening. Substantial equivalence was claimed based on this similar effect.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size for the "bench studies."
Data Provenance: The document does not specify the country of origin. It indicates the studies were "bench studies," which are laboratory-based, not clinical, and thus do not typically involve human subjects or retrospective/prospective data collection in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Bench studies typically rely on physical measurements and established protocols rather than expert consensus on images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Bench studies for physical devices primarily involve direct measurement and quantification of performance characteristics against a standard or predicate, not adjudication of interpretations as seen in diagnostic imaging.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and not provided. This device is a laser system for tooth whitening, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not directly applicable in the context of an AI algorithm. However, the "bench studies" assess the laser system's direct performance (its ability to activate bleaching materials) in a standalone manner, without human intervention in the mechanism of activation. The system itself is the "standalone" entity being evaluated for its physical function.

7. The Type of Ground Truth Used

The ground truth for the bench studies would be based on physical measurements and established scientific principles related to the activation of bleaching materials. This would likely involve quantifiable metrics of bleaching effectiveness or energy transfer, compared against the predicate device's known performance. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Ceralas Diode Laser System is a physical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided for the same reason as point 8.

Summary

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OCT 1 4 1999

99 3002

510(k) Summary Ceralas Diode Laser System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitted by: CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611

Contact Person: Carol Morello, V.M.D. Date prepared: September 2, 1999

Name of Device and Name/Address of Sponsor

Ceralas Diode Laser System (Model D15) CeramOptec. Inc. 515 Shaker Road East Longmeadow, MA 01028

Classification Name

Surgical laser

Predicate Device

American Dental Technologies Plasma Arc Curing System

Intended Use

The Ceralas D Laser System that is subject to this 510(k) notice is an instrument intended for light activation of bleaching materials for tooth whitening. This indication is added to the already cleared indications for use.

Technological Characteristics and Substantial Equivalence

The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System, which has already been cleared by FDA. The cleared Ceralas D Laser

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System is a complete self-contained compact surgical laser that utilizes gallium aluminum arsenide (GaALAs) semiconductor diodes to generate near-infrared laser radiation. The laser employs a modular design comprised of: (1) a laser diode: (2) a cooling module containing the laser diode, thermoelectric coolers, heat sink fins and fans; (3) an optics module containing a beamsplitter for control of optical power; (4) front control and display panel; and (5) RFIshielded, transformer power supply and control electronics. Interchangeable fiber optic delivery systems are coupled to the laser via an SMA 905 connector to deliver laser radiation to the target tissues. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module.

The wavelength for the Ceralas D Laser System is 980 ± 30nm, and its laser aiming beam wavelength is 635mm+10mm. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath.

Although the Ceralas D 980nm Diode laser is different technologically from the predicate device the effect of the laser used as a light source is equivalent to that of the PAC System as demonstrated by the attached study. In summary although there are differences the intended use and effect on the tissue is similar and no new questions of safety or efficacy are raised.

Performance Data

Bench studies demonstrated that the Ceralas D 980nm Laser System performed similarly to the PAC light for light activation of bleaching materials for teeth whitening.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Carol J. Morello, V.M.D. Regulatory Affairs CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Re: K993002 Trade Name: Ceralas Diode Laser System (Model D15) Regulatory Class: II Product Code: GEX Dated: September 2, 1999 Received: September 7, 1999

Dear Dr. Morello:

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 enclosures) 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.

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Page 2 - Carol J. Morello, V.M.D.

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.

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

Enclosure

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Page I of l

K993002 510(k) Number (if known):

Ceralas Diode Laser System (Model D15) Device Name: .

Indications For Use:

· Intended for light activation of bleaching materials for teeth whitening.
Note: This is an additional indication to the already cleared indications for use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K953002
510(k) Number

(Optional Format 3-10-98)

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.