PULSEMASTER

K961136 · American Dental Technologies, Inc. · GEX · Jun 3, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961136
• Device Name: PULSEMASTER
• Applicant: American Dental Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K961136 · Jun 3, 1996	PULSEMASTER	American Dental Technologies, Inc.	Independent clinical studies; Patient-reported daily calendars; Case studies	The submission uses results from independent clinical studies and case reports to demonstrate the effectiveness and safety of the PulseMaster laser for treating aphthous ulcers, comparing outcomes to standard care.	Aphthous ulcers; Nd:YAG laser; Patient-reported outcomes; Case studies

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Observational/Clinical study with patient-reported daily calendars; Follow-up/Duration: 6 to 18 months	21 patients (8 with recurrent aphthous ulcers, 14 with herpes labialis); Sample Size: 21	Untreated, control lesions in each patient	Pain relief, healing time, recurrence rate
Case series	Patients with recurrent aphthous ulcers; Sample Size: 3	Not applicable for this study	Discomfort, postoperative problems, symptom relief

Indications for Use

The use of the PulseMaster laser for treatment of aphthous ulcers.

Device Story

PulseMaster is a pulsed Nd:YAG dental laser system; used by dental professionals for intraoral soft tissue procedures. Device delivers laser energy to target tissue; facilitates ablation and coagulation. New indication involves treatment of aphthous ulcers; provides immediate pain relief and accelerated healing. Clinical application involves direct laser exposure to lesions; no reported side effects or contraindications. Benefits include immediate palliation and reduced severity of recurrences.

Clinical Evidence

Two studies presented. Study 1: 21 patients (8 aphthous, 14 herpes labialis) followed 6-18 months. Results for aphthous ulcers: 63% reported immediate pain relief, 50% faster healing, 50% no recurrence at 6 months, 75% of remainder reported less severe recurrences. Study 2: 3 case studies; reported immediate pain relief, no discomfort during/after procedure, no side effects.

Technological Characteristics

Pulsed Nd:YAG laser system. Designed for intraoral soft tissue surgical applications including ablation and coagulation.

Indications for Use

Indicated for the treatment of aphthous ulcers in patients suffering from recurrent aphthous ulcers.

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 laser (legally marketed for coagulation and ablation of intraoral soft tissue)

Submission Summary (Full Text)

{0}

JUN - 3 1996

K961136

American Dental

Technologies

# 510(k) Summary

## Device Name:

Trade Name: PulseMaster

Common Name: Dental Laser System

Classification Name: Surgical Laser System

Indication for Use: Aphthous Ulcers

## Submitter:

American Dental Technologies, Inc.

125 Shoreway Road

Suite 3000

San Carlos, CA 94070

## Contact Person:

Michael Yessik

Tel.: [phone]

Fax: [phone]

## Date Prepared:

March 19, 1996

125 Shoreway Road • Suite 3000 • San Carlos, CA 94070 • [phone] Fax [phone]

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510(k) Summary

This 510(k) Premarket Notification is for a new indication for use for the legally marketed PulseMaster laser family. The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for coagulation and ablation of other intraoral soft tissue.

Independent studies have been carried out using a pulsed Nd:YAG laser to treat aphthous ulcers. In one study, 21 patients were treated, eight with recurrent aphthous ulcers and 14 with herpes labialis lesions. The patients were evaluated over a period ranging from six months to eighteen months and the patients were asked to keep a daily calendar over that time period. The study was begun with both treated lesions and untreated, control lesions in each patient. However, all lesions were treated before the end of the study. Results were based on both the investigator’s evaluation at follow-ups and the patient’s self evaluation. For those with aphthous ulcers, immediate relief of pain was reported in 63% of the patients, 50% reported faster healing, 50% had no recurrence within 6 months and 75% of the remaining group reported less severe recurrences. The authors concluded that the pulsed Nd:YAG laser treatment was effective in the control and relief of most aphthous lesions.

In another study using a pulsed Nd:YAG laser for treatment of recurrent aphthous ulcers, three case studies were presented. The patients reported no discomfort during the procedure and no postoperative discomfort or other problems. The patients reported immediate relief of the painful symptoms of the lesions. The authors’ conclusion was that the laser treatment compared favorably with other treatments due to no side effects or contraindications, and immediate palliation of the lesions.

The results of these studies allow the following conclusions:

- The use of the PulseMaster laser for treatment of aphthous ulcers is substantially equivalent to the use of the PulseMaster laser for ablation and coagulation of other intraoral soft tissues.
- There are no new safety risks for this laser procedure.
- The laser treatment for recurrent aphthous ulcers is equivalent to the standard of care for treatment of recurrent aphthous ulcers in terms of effectiveness.