PULSEMASTER 1000 ST DENTAL LASER SYSTEM

K972325 · American Dental Technologies, Inc. · GEX · Sep 19, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972325
• Device Name: PULSEMASTER 1000 ST DENTAL LASER SYSTEM
• Applicant: American Dental Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures: - lesion (tumor) removal - biopsies - fibroma removal - frenectomies and frenotomies - gingivoplasties - gingivectomies - leukoplakia - operculectomies - oral papillectomies - aphthous ulcers - 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 loss, and tooth mobility.

Device Story

Portable diode laser system for intraoral soft tissue surgery; ablates, incises, excises, and coagulates tissue. Uses contact fiber optic delivery system. Operated by dental professionals in clinical settings. Device provides performance characteristics similar to Nd:YAG lasers. Output affects tissue via thermal coagulation and ablation; aids in periodontal pocket management and various soft tissue procedures. Benefits include improved clinical indices like gingival index and probe depth.

Clinical Evidence

Bench testing only. In vitro study compared PulseMaster 1000 Nd:YAG system to a diode laser with identical output parameters. Measured width/depth of tissue removal, lateral/deep thermal coagulation, and underlying tissue temperature rise. Results showed diode performance equal to or better than Nd:YAG, with no detrimental thermal effects expected.

Technological Characteristics

Portable diode laser system; contact fiber optic delivery; software-controlled; continuous or pulsed (gated) mode. Conforms to IEC 601 series electrical standards.

Indications for Use

Indicated for intraoral soft tissue procedures including lesion removal, biopsies, fibroma removal, frenectomies, frenotomies, gingivoplasties, gingivectomies, leukoplakia, operculectomies, oral papillectomies, aphthous ulcers, and sulcular debridement in patients requiring soft tissue management.

Regulatory Classification

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.

Predicate Devices

• PulseMaster® 1000 Dental Laser System (K922901)
• Aurora™ Diode Laser System (K954316)

Submission Summary (Full Text)

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K972325

SEP 1 9 1997

510(k) Summary

for

# PulseMaster® 1000 ST Dental Laser System

#### SPONSOR INFORMATION 1.

American Dental Technologies, Inc. 28411 Northwestern Highway Southfield, MI 48034

Mr. John G. Sulewski Contact: 248-353-5300 Telephone:

Date Prepared: June 20, 1997

#### 2. DEVICE NAME

| Proprietary Name: | PulseMaster® 1000 ST Dental Laser System |
|------------------------|------------------------------------------|
| Common/Usual Name: | Dental Laser System |
| Classification Name: | Laser Surgical Instrument |
| Classification Status: | Class II |

#### PREDICATE DEVICES 3.

- PulseMaster® 1000 Dental Laser System . American Dental Technologies, Inc. K922901
- Aurora™ Diode Laser System . Premier Laser Systems, Inc. K954316

#### DEVICE DESCRIPTION AND INTENDED USE 4.

The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended for ablating, incising, excising, and coagulating intraoral soft tissue

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(including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is software-controlled and utilizes high brightness diode laser technology to provide similar performance characteristics to Nd:YAG lasers.

#### TECHNOLOGICAL CHARACTERISTICS 5.

The PulseMaster® 1000 ST Dental Laser System is similar in design, function, and intended use to the predicate surgical dental laser systems identified above. The Aurora System is also a diode laser which operates in a continuous or pulsed (gated) mode with similar wavelength range to the PulseMaster® 1000 ST. All three devices are software-controlled, utilize the same type of generic fiber optic delivery system, and have similar performance characteristics with respect to tissue effects.

#### 6. DEVICE TESTING

Testing conducted on the PulseMaster® 1000 ST Dental Laser System includes software verification and validation, and conformance to all relevant requirements of the IEC 601 series of electrical standards.

An in vitro study compared the performance of the PulseMaster® 1000 Nd: YAG System to a diode laser system with output parameters identical to those of the PulseMaster® 1000 ST System. Comparison of width and depth of tissue removed, lateral and deep thermal coagulation, and temperature rise in underlying tissue showed that the performance of the diode laser system was the same or slightly better than that of the Nd: YAG system. No detrimental effects due to temperature or coagulation would be expected for either system during typical clinical usage for oral soft tissue applications.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol resembling an eagle or bird in flight. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. John G. Sulewski .Product Manager American Dental Technologies 28411 Northwestern Highway Southfield, Michigan 48034

SEP 1 9 1997

Re: K972325

> Trade Name: PulseMaster® 1000 ST Dental Laser System Regulatory Class: II Product Code: GEX Dated: June 20, 1997 Received: June 23, 1997

Dear Mr. Sulewski:

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 requirements , 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 - Mr. John G. Sulewski

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 [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,

ia 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 (if known): _ K 972321

PulseMaster® 1000 ST Dental Laser System Device Name: _

## Indications For Use:

The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures:

- lesion (tumor) removal ●
- biopsies ●
- fibroma removal ●
- frenectomies and frenotomies ●
- gingivoplasties
- gingivectomies ◆
- leukoplakia .
- . operculectomies
- . oral papillectomies
- . aphthous ulcers
- 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 loss, and tooth mobility.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices Kq 72325
510(k) Number

Prescription Use ***_***
(Per 21 CFR 801.109)
OR
Over-The-Counter Use **_**