THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM

K050342 · Theralase, Inc. · NHN · Jul 11, 2005 · Physical Medicine

Device Facts

• Record ID: K050342
• Device Name: THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
• Applicant: Theralase, Inc.
• Product Code: NHN · Physical Medicine
• Decision Date: Jul 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.

Device Story

The Theralase TLC-1000 is a non-heating infrared lamp system used for pain relief. It consists of a handheld probe containing 5 x 905 nm NIR laser diodes and 4 x 660 nm visible red laser diodes, connected to a battery-powered controller. Operated by clinicians within chiropractic practice, the device delivers laser energy to the knee area. The output is used as an adjunct to standard care to provide temporary pain relief. Clinical benefits include reduced pain levels in patients with moderate to severe knee symptoms who have failed conservative therapy.

Clinical Evidence

Prospective, single-blind, randomized study at three U.S. sites (n=122 adults, age 18+). Subjects had moderate to severe knee pain, failed conservative therapy, and no prior knee surgery. Primary endpoint: change in pain scores. Results: Active laser group showed statistically significant improvement over sham (p < 0.05 at 12th session; p < 0.01 at 30-day follow-up). Responder rate: 92.4% (active) vs. sham group. No adverse effects reported.

Technological Characteristics

Non-heating infrared lamp; 21 CFR 890.5500. Handheld probe with 5 x 905 nm NIR laser diodes and 4 x 660 nm visible red laser diodes. Rechargeable battery-powered controller unit.

Indications for Use

Indicated for adjunctive temporary relief of pain associated with knee disorders in adults 18 years and older who have failed conservative therapy and have not had previous knee surgery.

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.

Submission Summary (Full Text)

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# KOSO342

JUL 1 1 2005

### SUMMARY OF SAFETY AND EFFICACY

## Theralase™ Inc.

# TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM

### April 215t, 2005

#### GENERAL INFORMATION l.

| Device Generic Name: | TLC-1000 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Theralase TLC-1000 Therapeutic Medical Laser System |
| Device Classification: | Class 2, Performance Standards<br>21 CFR Part 890.5500 - Infrared Lamp, Non-Heating |
| Product Code: | NHN |
| Applicant Name and Address: | Theralase Inc.<br>600 Alden Road, Suite 101<br>Markham, Ontario<br>L3R 0E7, CANADA<br>Phone: [1]-905-947-8455<br>Fax: [1]-905-947-8550 |
| 510(k) Number: | K050342 |

#### DEVICE DESCRIPTION II.

The Theralase™ TLC-1000 Therapeutic Medical Laser System is a non-heating infrared lamp as defined in 21 CFR 890.5500. The TLC-1000 system is a precision medical device as wontion of a hand held portable multiple laser probe (5 x 905 NIR laser diodes and 4 x 660 visible red laser diodes) and a laser controller unit with a rechargeable battery.

#### INDICATIONS FOR USE lll.

The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.

#### ALTERNATIVE PROCEDURES OR PRACTICES IV.

The primary alternatives for use in treating chronic or acute knee pain include the use of TENS, steroids, non-steroidal anti-inflammatory drugs (NSAIDS) and barbiturated drugs (known to be addictive and relatively toxic).

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K050342

#### SUMMARY OF CLINICAL STUDIES V.

The Theralase™ TLC-1000 Therapeutic Medical Laser System was evaluated in a The Theralase - TLC-1000 Therapeatio Modical tudy that compared the "Active" Laser with prospective, single billid, fandomized ochtronical ducted at three investigational sites in the a Shaff Laser. The multi ochor study included a total of 122 adult male and female subjects Offited States of Amentod. The Stady the following conditions were met: diagnosis of To years and older. Enfoliment oooured in the followith a pain level of at least 4 as measured Knee pain ulsolder, modelate to severe symptomating while and failed conservative therapy by a f ain Ecver Abousement who had not had previous knee surgery.

### Clinical Data Analysis and Results

Statistical analyses were performed by generally accepted statistical techniques to evaluate Statistical analyses were performed by gonomiry desepted and prethe differences between the VAO soorco from pro treatingts in Group A (Active Laser) and Group B (Sham Laser).

The statistical analyses of the data demonstrate that the difference between the two TTIe Statistical analyses of the Gata demonomount.o the unt (p-value < 0.05 at the 12" treatment session and p-value < 0.01 at the 30 day post-treatment follow up).

The Theralase™ TLC-1000 Therapeutic Medical Laser System responder rate was 92.4% for The Theralase - TEO 1000 Therapount the end of the laser treatment sessions and 30 day Subjects in the "Active" Easer group at the one of the subjects treated with the "Sham" Laser.

No adverse effects from the laser treatments were observed by the principal investigators during the clinical investigational study.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL I 1 2005

Mr. Roger White President and CEO Theralase Incorporated 600 Alden Road, Suite 101 Markham, Ontario L3R OE7 (Canada)

Re: K050342

K030542
Trade/Device Name: Theralase™ TLC-1000 Therapeutic Medical Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-heating for adjunction use in pain therapy Regulatory Class: II Product Code: NHN Dated: April 28, 2005 Received: April 29, 2005

Dear Mr. White:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector 910(s) presidentially equivalent (for the indications ferenced above and nave determined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device American For de Free commerce prior to May 20, 1976, the excerdance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that do not require approvine approvisions of the Act. The You may, therefore, market the devices, basyer revents for annual registration, listing of general Controls provisions of the Free labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (560 addre) arols. Existing major regulations affecting your device
it may be subject to such additional controls. It hay be subject to such additional venevaliations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of receits concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA s issuation of a business with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I edical statutes and regalations and limited to: registration and listing (21 Comply with an the Act 31equirements)01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Mr. Roger White

This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the support of a list of a location to the legal This letter will allow you to begin maketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of type, premarket notification. The IDA Intellig of substantal organ in the spermits your device to proceed to the market. ..

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation and 10 10 10 10 10 10 15 - Algo, please note the regulati If you desire specific advice for your device of our of ... Also, please note the regulation entitled, contact the Urice of Comphance at (210) 216 of 807.97). You may obtain
"Misbranding by reference to premarket notification the Original of Small "Misbranding by reference to premarket notification (cr on on the Division of Small
other general information on your responsibilities under the Act from the Division of Smal other general information on your responsionities and its toll-free number [phone] or 1 Manufacturers, International and Consulter Assistance as to comments of the industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known): K050342

Theralase™ TLC-1000 Therapeutic Medical Laser System Device Name: ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

### Indications For Use:

The Theralase™ TLC-1000 Therapeutic Medical Laser System is indicated for The Theralase - TEC-1000 Therapoutio Mouloal Labor by of The There disorders with standard chiropractic practice.

Prescription Use: X
(Per 21CFR 801 Subpart D)

AND/OR

Over the Counter Use: (21 CFR 807 Subpart C)

(Please Do not WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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