CURAE'LASE CL1000 IR LASER SYSTEM

K053201 · Curae'Lase, Inc. · ILY · Dec 9, 2005 · Physical Medicine

Device Facts

• Record ID: K053201
• Device Name: CURAE'LASE CL1000 IR LASER SYSTEM
• Applicant: Curae'Lase, Inc.
• Product Code: ILY · Physical Medicine
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CL1000 IR Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Story

CL1000 IR Laser System is a non-invasive, hand-held therapeutic device. It consists of a control unit and a handheld treatment probe. The device emits infrared energy to provide continuous heat therapy. It is used to elevate tissue temperature for temporary pain relief, increased circulation, and muscle relaxation. Operation involves the user applying the probe to the target area. The device is intended for prescription use. It benefits patients by providing localized thermal therapy for musculoskeletal conditions.

Clinical Evidence

Bench testing only. The device underwent functional performance and electrical safety testing in accordance with applicable standards for infrared lamp medical devices. No clinical data was provided.

Technological Characteristics

Hand-held therapeutic device; infrared and visible laser diodes; control unit with electronics; non-invasive; continuous heat therapy delivery. Complies with 21 CFR 890.5500.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, or muscle spasm, and for temporary increase in local blood circulation or muscle relaxation.

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

• Meditech International Inc BioFlex Professional Therapy System (K023621)
• Dynatronics Solaris D890 Therapy Probe (K040729)
• Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179)
• Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986)
• Spectrum Laser & Technologies, Inc. Neurolase Series (K032787)

Submission Summary (Full Text)

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DEC 9 2005

510k Notification CL1000 IR Laser System November 15, 2005

# APPENDIX B

K05320/

# 510(k) PREMARKET NOTIFICATION SUMMARY

(per 21 CFR 807.92)

## CL1000 IR Laser System

I. Applicant:

Curae Lase Inc. 2315 Hwy 701 South Loris, SC 29569 843 - 455-7020

Date Prepared:

November 15, 2005

### II. Device Name

Proprietary Name: Common / Usual Name: Classification Name: Product Code:

CL1000 IR Laser System Infrared Lamp Infrared Lamp (21 CFR 890.5500) ILY

#### III. Intended Use of the Device

The CL1000 IR Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

### IV. Predicate Devices

Predicate devices to the CL1000 IR Laser System include, but not limited to, the Meditech International Inc BioFlex Professional Therapy System (K023621), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process.

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### V. Description of the Device

The CL1000 IR Laser System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.

### VI. Summary of the technical characteristics of the CL1000 IR Laser System to the referenced predicate devices

The CL1000 IR Laser System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.

### VII. Testing

Testing of the CL1000 IR Laser System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.

## VIII. Conclusions

Pursuant to the testing and comparison to the predicate devices, the CL1000 IR Laser System has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 9 2005

Curae'Lase Inc. C/O M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 12101- A Cullen Blvd. Houston, Texas 77047-2951

Re: K053201

Trade/Device Name: CL1000 IR Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamps Regulatory Class: Class II Product Code: ILY Dated: November 15, 2005 Received: November 23, 2005

Dear Ms. Heinrich:

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

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## Page 2 - Ms. H. Joyce Heinrich

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. 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 yours,

2

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510k Notification CL1000 IR Laser System November 15, 2005

## APPENDIX C

## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Pending KOS 3201

Device Name:

Curae Lase Inc. CL1000 IR Laser System

Indications for Use:

The Cl1000 IR Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Prescription Use: X X (Part 21 CFR 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 (ODDE)

Z

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

510(k) Number_KOS3201