LASER TOUCHONE

K083822 · Laser Health Technologies, LLC · GZJ · May 6, 2009 · Neurology

Device Facts

• Record ID: K083822
• Device Name: LASER TOUCHONE
• Applicant: Laser Health Technologies, LLC
• Product Code: GZJ · Neurology
• Decision Date: May 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LaserTouchOne™ is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of post-surgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Device Story

LaserTouchOne™ is a rechargeable, hand-held device combining low-level laser therapy (LLLT) and transcutaneous electrical nerve stimulation (TENS) for pain management. Device delivers laser light via a single diode (<1 mW, 670 nm) and pulsed electrical stimulation of low magnitude. Used in clinical or home settings; operated by patients or clinicians. Requires application of electroconductive gel. Output provides symptomatic relief of chronic, intractable, post-surgical, and post-traumatic pain. Clinical benefit derived from combined therapeutic modalities.

Clinical Evidence

Clinical trial conducted comparing the device to one TENS predicate and one low-level light predicate. No specific statistical metrics (p-values, CIs) provided in the summary.

Technological Characteristics

Hand-held, rechargeable unit. LLLT component: single diode laser, <1 mW, 670 nm. TENS component: pulsed electrical stimulation. Includes power recharging unit and electroconductive gel.

Indications for Use

Indicated for patients experiencing chronic, intractable pain, post-surgical acute pain, post-traumatic acute pain, or minor chronic neck and shoulder pain of musculoskeletal origin.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Rebco Trading Co., Pro Med 100 (K822854)
• Stargate International, Inc., Quantum Light Therapy System (K032816)
• Xanacare Technologies, Inc., ComboCare 2000 (K081141)
• Biomedical Design Instrumments, Electro-Acuscope 85 (K883911)

Submission Summary (Full Text)

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6083822

## 510(k) SUMMARY- LaserTouchOne™

Submitter Name: Laser Health Technologies, LLC

Submitter Address: 10234 North 58\$^{th}\$ Place
Paradise Valley, AZ 85253

Contact Person: James Mantle, Manager

Phone Number: 602-821-1659

Date Prepared: April 21, 2009

Device Trade LaserTouchOne™
Name:

Device Common Low level (cold) laser device (LLLT) and transcutaneous
Name: electrical nerve stimulator (TENS) for pain therapy

Classification 21 CFR 890.5500; 21 CFR 882.5890
Numbers:

Classification Non-heating lamp, for adjunctive use in pain therapy;
Names: Transcutaneous electrical nerve stimulator

Product Codes: NHN; GZJ

Predicate Devices: Rebco Trading Co., Pro Med 100 (K822854)

Stargate International, Inc., Quantum Light Therapy System
(K032816)

Xanacare Technologies, Inc., ComboCare 2000 (K081141)

Biomedical Design Instrumments, Electro-Acuscope 85
(K883911)

Statement of The LaserTouchOne™ is a low level laser and electrical
Intended Use: stimulation device. This combination of low level light and
electrical stimulation provides symptomatic relief of chronic,
intractable pain, and is indicated for adjunctive treatment of
post-surgical and post-traumatic acute pain and for adjunctive
use in providing temporary relief of minor chronic neck and
shoulder pain of musculoskeletal origin.

MAY - 6 2009

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The LaserTouchOne™ device is a rechargeable hand-held pain Device Description: therapy device. It combines the technology of low level laser and transcutaneous electrical nerve stimulation in one unit. The low level (cold) laser therapy is delivered with a single diode laser of <1 mW, 670 nm, and the pulsed electrical stimulation is of low magnitude. The device is provided with a power recharging unit and a tube of electroconductive gel.

Comparison to the Predicate Devices:

This device, with respect to performance in a clinical trial in which it was compared to one of the TENS predicate devices and to the low level light predicate device, its intended use, and the device characteristics, is substantially equivalent to the technologies provided by the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black.

Public Health Service

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laser Health Technologies, LLC. % Ms. Patsy Trisler 5600 Wisconsin Avenue Suite 509 Chevy Chase, Maryland 20815

## Re: K083822

Trade/Device Name: LaserTouchOne TM Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ, NHN Dated: April 21, 2009 Received: April 21, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Patsy Trisler

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Daniel Krone

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K083822

Device Name:

LaserTouchOne™

Indications for Use:

The LaserTouchOne™ is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of postsurgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Prescription Use × (Part 21 CFR 801 Subpart D)

ત્ત્વ

(Posted November 13, 2003)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083822