The Ceralas D10 Laser System that is the subject of this 510(k) notice is intended for the following dental indications on intraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenctomy, frenotomy, biopsy, operculectorny, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy and pulpotomy as an adjunct to root canal therapy.

The Ceralas DlO Diode laser is indicated for the following dental indications on intraoral and extraoral soft tissue (including marginal and interdental gingiva : and epithelial lining of free gingiva); frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor sites, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, and pulpotomy as an adjunct to root canal therapy.

Device Description

The Cerals D10 Diode Laser operates with a power range of 1-10W 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

The provided 510(k) submission for the Ceralas D10 Diode Laser System states "None required" for "Performance Data." This indicates that the device's acceptance criteria were not established through a specific performance study in this submission, but rather through a claim of substantial equivalence to a predicate device. Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document.

However, based on the provided text, here's what can be stated:

1. A table of acceptance criteria and the reported device performance

Not applicable. The document explicitly states "Performance Data: None required." The acceptance was based on substantial equivalence to a predicate device, not on specific performance metrics demonstrated in a study for this device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No performance study was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No performance study was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No performance study was conducted.

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

Not applicable. This device is a laser system, not an AI diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No performance study requiring ground truth was conducted for this device.

8. The sample size for the training set

Not applicable. No performance study involving a training set was conducted for this device.

9. How the ground truth for the training set was established

Not applicable. No performance study involving a training set was conducted for this device.

Explanation from the document:

The 510(k) submission explicitly states:

"Performance Data: None required."
"There are no technological differences between the Ceralas D10 Laser System and the Premier Laser Systems Aurora Diode Laser.. The Ceralas D10 Laser System's principles of operation, function and intended use are similar to Premier Laser System's Aurora Diode Laser System and no new questions of safety or effectiveness are raised."

This indicates that the FDA's acceptance of the Ceralas D10 Diode Laser System was based on its substantial equivalence to the legally marketed Premier Laser System's Aurora Diode Laser, meaning it operates on the same principles and has the same intended use, and therefore, no new performance data or separate clinical studies were deemed necessary for this specific submission.

Summary

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K992773

SEP - 1 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 (413) 525-0600 Phone: Facsimile: (413) 525-0611

Contact Person: Carol J. Morello, V.M.D. Date prepared: August 17, 1999

Name of Device and Name/Address of Sponsor

Ceralas Diode Laser System (Model D10) CeramOptec. Inc. 515 Shaker Road East Longmeadow, MA 01028

Classification Name

Surgical laser

Predicate Device

Premier Laser System' Aurora Diode Laser

Intended Use

MITRE ATT&CK

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aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy and pulpotomy as an adjunct to root canal therapy.

There are no technological differences between the Ceralas D10 Laser System and the Premier Laser Systems Aurora Diode Laser.. The Ceralas D10 Laser System's principles of operation, function and intended use are similar to Premier Laser System's Aurora Diode 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 U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 1999

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

K992773 Re:

Trade Name: Ceralas D10 810nm Diode Laser System Regulatory Class: II Product Code: GEX Dated: August 17, 1999 Received: August 18, 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 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, 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,

Colin M. Witwer, 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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Page_of_______________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K992773

Device Name: Ceralas D10 810nm Diode Laser System

Indications For Use:

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	Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use(Per 21 CFR 801.109)	X
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(Optional Format 3-10-98)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992773

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.