THOR DDII 830CL3 LASER SYSTEM

K030226 · Thor Intl. · NHN · Feb 10, 2003 · Physical Medicine

Device Facts

• Record ID: K030226
• Device Name: THOR DDII 830CL3 LASER SYSTEM
• Applicant: Thor Intl.
• Product Code: NHN · Physical Medicine
• Decision Date: Feb 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The THØR DDII 830CL3 Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

Device Story

Handheld, non-invasive, low-energy, non-heating infrared therapeutic laser; utilizes three 30mW Gallium Aluminum Arsenide (GaAlAs) laser diodes; delivers 90mW total output power at 830nm wavelength. Device emits invisible photonic energy to tissue for pain management. Used as adjunct treatment for Carpal Tunnel Syndrome. Operated by healthcare professionals in clinical settings. Output is non-thermal photonic energy; clinical decision-making relies on provider assessment of pain relief. Benefits include temporary reduction of hand and wrist pain.

Clinical Evidence

Bench testing only. Includes functional performance testing and electrical safety testing (EN60601-1, EN 60601-2-22, EN60601-1-2). No clinical trial data presented.

Technological Characteristics

Non-heating infrared lamp; 3x 30mW GaAlAs laser diodes (90mW total); 830nm wavelength. Complies with EN60601-1, EN 60601-2-22, EN60601-1-2. CE marked (Class IIb). Handheld form factor.

Indications for Use

Indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

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 830 Laser System (K010175)
• Acculaser Pro Low Level Laser System (K020657)
• MedX LCS System (K021985)

Submission Summary (Full Text)

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510(k) Notification THØR DDII 830CL3 System January 20, 2003

# APPENDIX C SUMMARY OF SAFETY AND EFFICACY

510(k) PREMARKET NOTIFICATION SUMMARY

FEB 1 0 2003

(per 21 CFR 807.92)

### THØR DDII 830CL3 Laser System

#### I. Applicant:

THØR International Ltd. Caer Sidhe Chiltern Road Amersham HP6 5PH United Kingdom Telephone: [phone] [phone] Facsimile: James Carroll Contact: [e-mail] e-mail M. Joyce Heinrich Contact Person: Texas Applied Biomedical Services, Inc. 12101 Cullen Blvd., # A Houston, Texas 77047 713 / 734-4433 telephone 713 / 734-5671 facsimile

#### II. Device Name:

| Proprietary Name: | THØR DDII 830CL3 Laser System |
|----------------------|---------------------------------|
| Common / Usual Name: | Low Level Laser System |
| Classification Name: | Infrared Lamp (21 CFR 890.5500) |
| Product Code: | NHN |

[e-mail] e-mail

#### III. Predicate Device

THØR DDII 830CL3 Laser System is substantially equivalent to other low level therapeutic lasers currently in commercial distribution. These predicate devices include the MicroLight Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process. The Therapeutic Laser System has the same intended use as and similar technological characteristics to these predicate devices.

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030226 2/2

#### IV. Intended Use of the Device

The THØR DDII 830CL3 Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

#### V. Description of the Device

THØR DDII 830CL3 Laser System is a handheld, non-invasive, low energy, nonheating infrared therapeutic medical laser that is intended for use as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. The THØR 830CL3 Laser System incorporates three 30 milliwatt (mW) Gallium Aluminum Arsenide (GaAlAs) laser diodes delivering a total output power of 90 milliwatts (mW) at 830 nanometer (nm) wavelength.

### Summary of the technical characteristics of the THØR DDII 830CL3 Laser VI. System to the referenced predicate device.

The THØR DDII 830CL3 Laser System and the aforementioned predicate devices are non-heating 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

Testing of the THØR DDII 830CL3 Laser System included functional performance testing and electrical safety testing.

The THØR DDII 830CL3 Laser System is manufactured to comply with the following European standards:

Medical Electrical Equipment Medical Laser Equipment EMC CE Marking Classification Medical Device Directive

EN60601-1: 1993 EN 60601-2-22:1996 EN60601-1-2: 1994 IIb, Certificate No. C10151 issued by SGS 93/42/EEC Annex II

### VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the THØR DDII 830CL3 Laser System has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic laser performance specifications as an adjunctive treatment for the relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

THØR DDII 830CL3 Laser System performs as intended and does not raise any new safety or efficacy issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

FEB 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

THOR International Ltd. c/o M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services, Inc. 12101 A Cullen Boulevard Houston, Texas 77047

Re: K030226

Trade Name: THOR DDII 830CL3 Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, Non-Heating for Adjunctive Use in Pain Therapy Regulatory Class: II Product Code: NHN Dated: January 17, 2003 Received: January 22, 2003

Dear Ms. Heinrich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - M. Joyce Heinrich

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/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark A. Milliman

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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### APPENDIX B

### STATEMENT OF INDICATIONS FOR USE

# STATEMENT FOR INDICATIONS FOR USE

Pending KO30226 510(k) Number (if known):

THØR DDII 830CL3 Laser System Device Name:

### Indications for Use:

The THØR DDII 830CL3 Laser System 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)

OR Over the Counter Use Prescription Use: (Optional Format 1-2-96) (per 21 CFR801.109) (Division Sign-Off) 510(k) Number _ េរោ Sivision of General Dosto Juve Jugical Devices 10(k) Number _________________________________________________________________________________________________________________________________________________________________