The Ceralas D Laser System that is the subject of this 510(k) notice is identical to the Ceralas D Laser System that has already been cleared by FDA (K983058) for use in the following dental indications: draining fistulas, coagulation and decontamination of extraction sites, frenectomy, excisional biopsy, operculectomy, implant uncovering, gingivectomy, gingivoplasty, degranulation of infrabony defects, enucleate apical troughing for crown and bridge, apthus ulcers, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, exposure of enamel for orthodontic brackets, and surgical exposure to aid in eruption. The purpose of this submission is to expand the indications for use to include pulpotomy and pulpotomy as an adjunct to root canal therapy.

Device Description

The Cerals D Diode Laser operates with a power range of 1-15W in the CW or pulsed mode. The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end.

AI/ML Overview

Here's an analysis of the provided text regarding the Ceralas Diode Laser System and its performance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
No new questions of safety or effectiveness are raised compared to predicate.	"The Ceralas D Laser System's principles of operation, function and intended use are similar to Premier Laser System's Pegasus Nd: YAG laser system and no new questions of safety or effectiveness are raised."
Technological identity with previously cleared device.	"There are no technological differences between the previously cleared Ceralas D Laser System and the device subject to this 510(k)submission."
Performance suitable for expanded dental indications (pulpotomy and pulpotomy as an adjunct to root canal therapy).	(No specific performance metrics are provided. The FDA's substantial equivalence decision implies that its performance is deemed adequate for these indications based on predicate comparison and the lack of new safety/effectiveness concerns).
Operates within specified power range and mode.	"The Cerals D Diode Laser operates with a power range of 1-15W in the CW or pulsed mode."
Utilizes specified delivery system.	"The delivery systems for the Ceralas D Laser System consist of optical fiber fitted with an SMA 905 connector at the proximal end."

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

The document explicitly states: "Performance Data: None required." This indicates that no new empirical test set data was used to demonstrate performance for this particular 510(k) submission. The device relies on demonstrating substantial equivalence to a predicate device and technological identity to a previously cleared version of itself for the expanded indications.

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

Since no performance data was required or submitted, there was no test set for which ground truth needed to be established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Performance Data: None required."

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

This device is a hardware laser system, not an algorithm. Therefore, a standalone performance study in the context of AI algorithms is not applicable.

7. The Type of Ground Truth Used

No new ground truth was established or used for this 510(k) submission as no performance data was submitted. The grounds for approval are based on predicate device comparison and the lack of technological differences from a previously cleared device.

8. The Sample Size for the Training Set

Not applicable. As a hardware device, there is no "training set" in the context of machine learning. The device's design and operating parameters would have been established through engineering and potentially prior clinical testing, but this 510(k) does not detail such information.

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

Not applicable, as there is no "training set" in this context. The core assertion is that the device, being technologically identical to a previously cleared one and similar to a predicate, is safe and effective for the expanded indications without requiring new performance data.

Summary

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991891

JUN 2 4 1999

510(k) Summary Ceralas Diode Laser System

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

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

Contact Person: Carol Morello, V.M.D. Date prepared: June 1, 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

Ceralas Diode Laser System (Model D15) Premier Laser System'Pegasus Nd: YAG Laser

Intended Use

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surgical exposure to aid in eruption. The purpose of this submission is to expand the indications for use to include pulpotomy and pulpotomy as an adjunct to root canal therapy.

There are no technological differences between the previously cleared Ceralas D Laser System and the device subject to this 510(k)submission. The Ceralas D Laser System's principles of operation, function and intended use are similar to Premier Laser System's Pegasus Nd: YAG laser system and no new questions of safety or effectiveness are raised.

Performance Data

None required.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1999

Carol J. Morello, VMD Manager, Regulatory Affairs CeramOptec. Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Re: K991891

Trade Name: Ceralas Diode Laser System (Model D15) Regulatory Class: II Product Code: GEX Dated: June 1, 1999 Received: June 3, 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 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 vour 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, VMD

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.

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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of I

510(k) Number (if known): ≤ 991891

Device Name: Ceralas D Diode Laser System

Indications For Use:

ﺮ

Pulpotomy

Pulpotomy as an adjunct to root canal therapy

NOTE: These are additional indications to the already cleared indications for market release in K983058.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Optional Format 3-10-98)

Acosta

Divisio [ Sision 5 : O(k) Nun

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.