PERIOLASE ND:YAG DENTAL LASER SYSTEM by MILLENNIUM DENTAL TECHNOLOGIES, INC.

The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental. general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising. excising. vaporization and coagulation of soft tissues using a contact fiber optic delivery The Sevice will be used in the following areas: general and cosmetic dentistry sy stem. otolary ngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the additional oral-pharngeal indications for use for which the device will be marketed:

. Selective ablation of enamel (first degree) caries
Exposure of unerupted / partially crupted teeth
Implant recovery ●
l.esion (tumor) removal .
Leukoplakia .
Pulpotomy
Pulpotomy as adjunct to root canal therapy
Romoval of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
Sulcular debridement (removal of diseased or inflamed soft tissue in the periodonal pecket) to improve clinical indiccs including gingival bleeding index, probe depth, attachment level and tooth mobility

The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage

Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frencctomy Frenotomy Gingival Incision and Excision Gingivectority Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment

Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility

Device Description

The PerioLase is an Nd:YAG laser producing laser emission at 1064nm. The laser consists of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.

AI/ML Overview

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary and FDA clearance letter for the PerioLase Dental Laser System. It focuses on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than presenting a study proving a device meets specific performance metrics.

Specifically, the "Clinical Performance Data" section explicitly states "N/A" (Not Applicable), and the "Summary Basis of Equivalence" states, "The PerioLase is essentially identical to the InPulse Laser System. The indications for use and intended uses are also identical. There are no new safety issues." This indicates that the clearance was based on similarity to already approved devices, not new clinical performance data or studies defining and meeting specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

Summary

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MAR 27 2002

Summary of Safety and Effectiveness Information PerioLase	MILLENNIUM DENTAL
Dental Laser SystemPremarket Notification, Section 510(k)	TECHNOLOGIES, INC.
	DECEMBER 13, 2001

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长014272

This 510(K) Summary of safety and effectiveness for the Millennium Dental Technologies PerioLase Dental Lase This Tit(L) Submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:	Millennium Dental Technologies, Inc.
Address:	10929 South Street, Suite 106-BCerritos, CA 90703
Contact Person:	David M. Harris, Ph.D.
Telephone:	(562) 860-2908 – Phone(562) 860-1799 - FAX
Preparation Date:	December 14, 2001
Device Trade Name:	PerioLase Dental Laser
Common Name:	Nd:YAG Pulsed Laser
Classification Name:	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878-48
Legally Marketed PredicateDevice:	InPulse Pulsed Nd:YAG LaserPulseMaster Dental LaserSunLase 800P Laser SystemDentica Dental Laser
Description of the MillenniumDental Technologies PerioLaseDental Laser	The PerioLase is an Nd:YAG laser producing laser emission at1064nm. The laser consists of two interconnected sections: Thecabinet which houses the laser head, the power supply, the coolingsystem and the microprocessor with control panel; and the fiberoptic delivery system.
Clinical Performance Data:	N/A
Summary Basis of Equivalence:	The PerioLase is essentially identical to the InPulse Laser System.

Laser System. The indications for use and intended uses are also identical. There are no new safety issues.

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	1014277
Dental Laser SystemPremarket Notification, Section 510(k)			Summary of Safety and Ellectiveness Information PerioLase MILLINNIUM DENTAL PERMITECHNOLOGIES, INCIANUARY 02, 2002

Intended use:

The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage

PerioLase.doc

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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 eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2002

Milfennium Dental Technologies, Inc. c/o David M. Harris, Ph.D. Bio-Medical Consultants, Inc. 4256 Heyer Avenue Castro Valley, California 94546

Re: K014272

Trade Name: PerioLase Dental Laser Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II Product Code: GEX Dated: December 13, 2001 Received: December 27, 2001

Dear Dr. Harris:

We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. David Harris

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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510(k) Number: K014272

Device Name(s): PerloLase Nd:YAG Dental Laser System

Intended Use(s) of the Device:

I'he PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental. general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising. excising. vaporization and coagulation of soft tissues using a contact fiber optic delivery The Sevice will be used in the following areas: general and cosmetic dentistry sy stem. otolary ngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the additional oral-pharngeal indications for use for which the device will be marketed:

. Selective ablation of enamel (first degree) caries
Exposure of unerupted / partially crupted teeth
Implant recovery ●
l.esion (tumor) removal .
Leukoplakia .
Pulpotomy
Pulpotomy as adjunct to root canal therapy
Romoval of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
Sulcular debridement (removal of diseased or inflamed soft tissue in the periodonal pecket) to improve clinical indiccs including gingival bleeding index, probe depth, attachment level and tooth mobility

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

PerioLase.doc

Over-The-Counter Use (Optional format 1-2-96)

Muriam C. Provoost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K6114272

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.