ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE

K020657 · Acculaser, Inc. · NHN · Jul 29, 2002 · Physical Medicine

Device Facts

• Record ID: K020657
• Device Name: ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
• Applicant: Acculaser, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acculaser Pro Low Level Laser Therapy Device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

Device Story

Acculaser Pro is a hand-held, non-thermal, low-level laser therapy (LLLT) device. It emits infrared energy at 830nm. Used by clinicians to provide temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome. Device functions as an adjunctive therapy; operates by delivering infrared light to target tissues. No complex software or automated analysis described.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Hand-held probe; non-thermal; infrared laser energy source; 830nm wavelength. No software or connectivity described.

Indications for Use

Indicated for patients experiencing hand and wrist pain associated with Carpal Tunnel Syndrome as an adjunctive therapy.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• MicroLight 830TM Laser System (K010175)

Submission Summary (Full Text)

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# JUL 2 9 2002

### Acculaser, Inc. Summary of 510(k) Premarket Notification K020657 Acculaser Pro Low Level Laser Therapy Device

## Introduction

According to the requirements of 21 CFR §807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

| 1) Submitter<br>Address: | Owner-Operator<br>Acculaser, Inc.<br>12526 High Bluff Drive, Suite 260<br>San Diego, CA 92130 |
|--------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Jackson Streeter, M.D., CEO |
| Telephone: | 858-214-2258 |
| Telefax: | 858-314-2355 |
| Email: | [e-mail] |
| Date Prepared: | April 30, 2002 |

- 2) Device Name:

| Proprietary name: | Acculaser Pro Low Level Laser Therapy |
|-------------------------------------------|-----------------------------------------------------------------------------|
| Common name: | Infrared laser |
| Classification Name(s) and Regulation(s): | Lamp, Non-Heating, for Adjunctive Use in Pain Therapy<br>(21 CFR §890.550); |
| Product Code: | NHN |

.

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- The Acculaser Pro Low Level Laser Therapy (LLLT) 3) Identification of device is substantially equivalent to MicroLight Predicate Devices to which Substantial Corporation of America's MicroLight 830TM Laser System; 510(k)-cleared by the FDA on February 6, 2002 Equivalence is claimed (K010175).
#### 4) Device Description

The Acculaser Pro LLLT has a hand-held treatment probe, is non-thermal, and emits infrared energy at 830nm.

| 5) Intended Use | The Acculaser Pro LLLT device is indicated for adjunctive use in the temporary relieve of hand and wrist pain associated with Carpal Tunnel Syndrome. |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|

#### 6) Technological Characteristics and Substantial Equivalence Conclusion

The Acculaser Pro LLLT device has the same indications for use and substantially equivalent technological characteristics as the MicroLight 830™ Laser System.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2002

Acculaser, Inc. c/o Patsy J. Trisler, J.D., RAC Senior Director, PharmaNet Consulting PharmaNet, Inc. 815 Connecticut Avenue, N.W. Suite 610 Washington, DC 20006

Re: K020657

Trade/Device Name: Acculaser Pro Low Level Laser Therapy Device Regulation Number: 21 CFR 890.5500 Regulation Name: Non-Heating, for Adjunctive Use in Pain Therapy Regulatory Class: II Product Code: NHN Dated: April 30, 2002 Received: April 30, 2002

Dear Ms. Trisler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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

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Page 2 - Ms. Patsy J. Trisler

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. 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 [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

R. Mark H. Millenson

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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K020657 510(k) Number (if known):

Device Name: Acculaser Pro Low Level Laser Therapy Device
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Indications For Use:

The Acculaser Pro Low Level Laser Therapy Device is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millerson

(Optional Format 3-10-98)

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

510(k) Number_