LASER-D68

K061656 · Laser Pain Clinics LP · GEX · Dec 15, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061656
• Device Name: LASER-D68
• Applicant: Laser Pain Clinics LP
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary: - Increase in local blood circulation - Relief of minor muscles and joint aches, pains and stiffness . - Relaxation of muscles . - . Relief of muscle spasms - . Relief of minor pain and stiffness associated with arthritis

Device Story

Laser-D68 is a non-invasive, low-energy infrared therapeutic laser system. Device consists of a driver unit and three interchangeable probes: Probe #1 (660nm InGaAlP diode, 1-50mW), Probe #2 (830nm GaAlAs diode, 20-400mW), and Probe #3 (904nm GaAs diode, 5-150mW). Used in healthcare centers, physical therapy labs, and doctor offices by clinicians to deliver photonic energy to target tissue. Provides topical heating to increase local blood circulation and relieve muscle/joint pain, stiffness, and spasms. Clinicians select probe and power settings based on therapeutic needs. Benefits include temporary pain relief and muscle relaxation through non-invasive light therapy.

Clinical Evidence

Bench testing only. Evidence includes electrical safety testing, laser safety testing, and electromagnetic compatibility testing. Device meets CFR 1040 requirements and is CE marked per Medical Devices Directive 93/42/EEC.

Technological Characteristics

Infrared lamp (21 CFR 890.5500). Emits photonic energy via laser diodes: 660nm (InGaAlP), 830nm (GaAlAs), and 904nm (GaAs). Adjustable power output ranges from 1mW to 400mW depending on probe. System comprises a driver unit and three interchangeable probes. Complies with 21 CFR 1040 laser safety standards and electromagnetic compatibility requirements.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint aches, pains, and stiffness; muscle relaxation; relief of muscle spasms; relief of minor pain/stiffness associated with arthritis; and increase in local blood circulation.

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

• Eltech s.r.l K-Laser (K050070)
• Advanced Medical Technologies Maestro MDTTL Laser System (K053473)

Submission Summary (Full Text)

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KO6/656

## 510(k) Summary (per 21 CFR 807.92)

DEC 1 5 2006

I. Applicant Laser Pain Clinics 300 N Highland, Suite 105 WNJ Medical Office Building Sherman, Texas 75092

| Contact Person: | Holly Wright, Manager and President<br>LaserMD Management GP, LLC (General Partner)<br>c/o LaserMD Management GP, LLC<br>903.868.1350 telephone<br>206.203.2001 Facsimile<br>e-mail: [e-mail] |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | November 6, 2006 |

#### II. Device Name

| Proprietary Name: | Laser-D68 |
|-----------------------|-------------------------------------|
| Common/ Usual Name: | Infrared Lamp |
| Classification Name: | Lamp, infrared, therapeutic heating |
| Regulation Number: | 890.5500 |
| Product Codes: | ILY |
| Classification: | 2 |
| Classification Panel: | Physical Medicine |

#### III. Predicate Device

Laser Pain Clinics is substantially equivalent to the Eltech s.r.l K-Laser (K050070) and the Advanced Medical Technologies Maestro MDTTL Laser System (K053473). The devices are therapeutic medical lasers designed to deliver light energy to the target tissue.

#### IV. Intended Use of the Device

Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary:

- Increase in local blood circulation �
- Relief of minor muscles and joint aches, pains and stiffness .
- Relaxation of muscles .
- . Relief of muscle spasms
- . Relief of minor pain and stiffness associated with arthritis

#### V. Description of the Device

The Laser-D68 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy in healthcare centers, physical therapy laboratories, and family doctor practices.

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The Laser D68 is supplied with three different probes that are used to generate, laser radiation when connected to the D68 driver unit. Probe #1 is a 660nm, Indium Gallium Aluminum Phoshpide (InGaAIP) laser diode (visible red light) with an adjustable treatment power output from 1 milliwatts (mW) to 50 milliwatts (mW) (in 1mW increments). Probe #2 is an 830nm, Gallium Aluminum Arsenide (GaAIAs) Iaser diode (infrared light) with an adjustable treatment power output from 20 milliwatts to 400 milliwatts (in 5mW increments). Probe #3 is a 904nm, Gallium Arsenide (GaAs) laser diode (infrared light) with adjustable treatment power output of either SmW to 90mW (in 5mW increments) (45W laser power source) or 5 mW to 150mW (in 5 mW increment) (75W modulated laser power source).

Each of the laser probes are fully interchangeable with the D68 driver.

### Summary of the Technical Characteristics for the Laser-D68 to the VI. referenced predicate devices.

The Laser-D68 and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices use infrared diodes to emit invisible photonic energy to tissue. The intended use is identical for all devices.

#### VII. Testing

The testing of the Laser-D68 included electrical safety testing, laser safety testing and electromagnetic compatibility testing.

#### Safety & Effectiveness VIII.

There are no substantial differences between the Laser-D68 defined in this 510(k) submission and the predicate devices. They are similar to the technologies that are currently used in other similar medical devices.

The Laser-D68 included electrical safety testing, laser safety testing and electromagnetic compatibility testing.

The Laser-D68 meets the applicable requirements of CFR 1040.

The Laser-D68, as with the predicate devices, has been certified to the requirements of the Medical Devices Directive 93/42/EEC, and is CE Marked

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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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laser Pain Clinics % Ms. Holly Wright Manager and President 300 N. Highland, Suite 105 Sherman, Texas 75092

DEC 1 5 2006

Re: K061656

Trade/Device Name: Laser D-68 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: November 6, 2006 Received: November 7, 2006

Dear Ms. Wright:

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 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 - Ms. Holly Wright

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**LASER**
PAIN CLINICS

# 4. Indication for Use Statement

510(k) Number (if known): K061656

Device Name: Laser D-68

Indications for Use:

Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary:

- Increase in local blood circulation ●
- Relief of minor muscles and joint aches, pains and stiffness .
- Relaxation of muscles
- Relief of muscle spasms
- Relief of minor pain and stiffness associated with arthritis

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of General Restorative,

and Neurological Devices

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| 510(k) Number | K061656 |
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| | K061656 MNM |