LC THERAPY, MODEL LCT-1000

K070400 · Litecure, LLC · ILY · Feb 28, 2007 · Physical Medicine

Device Facts

• Record ID: K070400
• Device Name: LC THERAPY, MODEL LCT-1000
• Applicant: Litecure, LLC
• Product Code: ILY · Physical Medicine
• Decision Date: Feb 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

LC Therapy, Model LCT-1000 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

Device Story

LCT-1000 is a compact medical laser system for topical heating. System consists of a laser source, flexible optical fiber, and lightweight wand. Operator enables laser via touch-screen display and foot switch; operates in continuous or pulsed mode. Used in clinical settings by trained personnel. Output is infrared laser energy delivered to patient tissue. Healthcare provider uses device to elevate tissue temperature for pain relief and increased circulation. Benefits include temporary relief of muscle/joint pain and stiffness. Safety requires protective eyewear for all personnel and removal of reflective objects to prevent eye damage.

Clinical Evidence

Bench testing only. Device performance demonstrated compliance with generally accepted therapeutic heat performance specifications by producing tissue temperature levels consistent with literature and FDA-accepted standards.

Technological Characteristics

Infrared laser system. Standards: 21 C.F.R. § 1040.10 & 1040.11, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22, IEC 61000-3-2, IEC 61000-3-3, IEC 60825-1. Features touch-screen interface, foot switch control, and flexible optical fiber delivery. Operates in continuous or pulsed modes.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle/joint pain, muscle spasm, pain/stiffness from arthritis, muscle relaxation, and increased local blood circulation. Contraindications: pregnant females (abdominal/lumbosacral areas), children (epiphyseal lines), patients with pacemakers (thorax/over pacemaker), thyroid gland, ovaries, testicles, and patients on heat/light-sensitive medications.

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

• K-Laser Therapy Probe (K050070)
• ALT Laser, Model VTR 75 (K031612)

Submission Summary (Full Text)

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## 510(k) SUMMARY

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The Summary of Safety and Effectiveness on the LiteCure, LLC. LCT-1000 laser reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

| Applicant | Brian Pryor<br>LiteCure, LLC<br>930 Old Harmony Road, Suite A<br>Newark, Delaware 19713 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | 302-709-0408 |
| Facsimile | 302-709-0409 |
| Date | December 20, 2006 |
| Name | LC Therapy, Model LCT-1000 Laser |
| Classification | Infrared Lamp, 21 CFR 890.5500 |
| Predicate: | K-Laser Therapy Probe - Cleared under K050070 market clearance date May 25, 2005 ALT Laser, Model VTR 75 - Cleared under K031612 market clearance date December 11, 2003 |
| Description | LC Therapy, Model LCT-1000 Laser is a compact medical laser system.<br>The laser light delivery system consists of a flexible optical fiber threaded<br>through a lightweight wand. Activation occurs when the operator enables<br>the laser and presses the foot switch. Release the foot switch to deactivate<br>the laser. Depending on laser system configuration, the foot switch can<br>function as on/off switch. A touch-screen display panel allows the<br>operator to adjust or set laser output level. The laser can operate in<br>continuous wave mode or controlled pulse mode. |
| Intended Use | LC Therapy, Model LCT-1000 is indicated for emitting energy in the<br>infrared Spectrum to provide topical heating for the purpose of elevating<br>tissue temperature for temporary relief of minor muscle and joint pain,<br>muscle spasm, pain and stiffness associated with arthritis and promoting<br>relaxation of the muscle tissue and to temporarily increase local blood<br>circulation. |
| Contraindications | Do not apply infrared light to abdominal or lumbosacral points in pregnant females. Do not apply infrared light to the epiphyseal lines in children. Do not apply infrared light to the thorax or over the pacemaker itself in patients with pacemakers. Do not apply infrared light over the thyroid gland, ovaries and testicles. Do not apply infrared light to patients who are taking drugs that have heat or light sensitive contraindications, such as but not limited to certain types of steroids. |
| Warning | Warning: Use carefully. May cause serious burns. Do not use over sensitive skin areas or in the presence of poor circulation. The unattended use of LiteCure LCT-1000 device by children or incapacitated persons may be dangerous. NEVER look directly into the distal end of the optical fiber connected to an active laser device, direct the laser light directly into the eyes, or direct the laser beam at anything other than the area to be treated WITH or WITHOUT the appropriate laser-emission protective eyewear. Indirect or direct eye contact with the output beam or at scattered laser light from any reflective surfaces from the laser will cause serious damage, irreparable corneal and/or retinal damage, and possible blindness to one or both eyes. DO NOT allow any reflective object to fall into or obstruct the path of the laser energy produced by this device. Scattered or reflected laser energy can cause serious damage to eyes. The operator, all assistants, and the patient must remove all reflective objects (such as rings, metal watchbands, and jewelry) prior to treatment with this device. Indirect or direct eye contact with the output beam or at scattered laser light from any reflective surfaces from the laser will cause serious damage, irreparable corneal and/or retinal damage, and possible blindness to one or both eyes. DO NOT remove protective eyewear until the operator returns the laser device to Standby mode. DO NOT use the System Controls or performance of procedures other than those specified in this manual may result in hazardous radiation exposure. DO NOT attempt to gain access to any internal device component. THERE ARE NO USER-SERVICEABLE COMPONENTS inside this laser device. Doing so may cause serious and/or irreversible injury. AVOID THE USE of flammable solvents, anesthetics, oxidizing gases such as nitrous oxide (N 2O) and oxygen or endogenous gases The high temperatures produced in normal use of the laser equipment may ignite some material, for example cotton or wool, when saturated with oxygen. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used. FAILURE TO COMPLY with all safety instructions and warnings may expose all participants to harmful levels of laser radiation and/or dangerous levels of electrical current. |
| Cautions: | Never allow untrained personnel to operate this advice unless directly supervised by a properly trained and experienced individual The protective eyewear supplied with this device has an optical density rating >5 in the 350nm~2000nm (see specification sheet) region. All personnel present during device operation must ware this eyewear. Contact LiteCure, LLC. at 302-709-0408 to purchase additional sets of protective eyewear for this device. Select a secure, properly equipped, and well-ventilated location in which to install and operate the laser. Place "Laser in use" signs at location entrances where people will use the LiteCure, LLC. laser device. Always put the laser in Standby mode or switch the device off prior to adjusting or preparing the wand or fiber optic. Never leave this device in the READY mode unattended. See the STANDBY to READY Mode in the Operations section of this manual. Remove the key from the device's key switch when not in use to prevent unauthorized and/or unqualified use of the device as well as inadvertent laser emissions. Turn the device off before relocating equipment in the same vicinity. Never press the foot switch without first verifying the safe orientation and proper positioning of the wand and distal end of the optical fiber and ensuring compliance to all safety precautions. During any laser procedure, do not allow any nonessential personnel into the treatment area. Never allow the untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual. ALWAYS clean the SMA fiber tip before inserting into the SMA emission port. A dirty tip could result in damage to the unit. Federal law (USA) restricts this device to sale by or on the order of a physician. |
| Substantial<br>Equivalency<br>Information | According to non-clinical testing, the Litecure LCT 1000 system has the same intended uses, functional and performance characteristics as the predicate devices listed. The testing demonstrated compliance to the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Food and Drug Administration. The identified differences were determined to be minor and do not raise any concerns regarding the overall safety and effectiveness of the device. |
| Technological<br>Characteristics | The device is subject to the following voluntary consensus standards: 21 C.F.R. § 1040.10 & 1040.11; IEC 60601-1; IEC 60601-1-2; IEC 60601-1-4; IEC 60601-2-22; IEC 61000-3-2; IEC 61000-3-3; and IEC 60825-1. |

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## 510(k) SUMMARY continued

The Summary of Safety and Effectiveness on the LiteCure, LLC. LC Therapy, Model LCT-1000 reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

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## 510(k) SUMMARY continued

The Summary of Safety and Effectiveness on the LiteCure, LLC. LCT-1000 Laser reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of fature studies and or tests may require alterations of the conclusions or recommendations set forth.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller font size.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Litecure, LLC % Intertek Testing Services Mr. Neil E. Devine, Jr. 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087

FEB 2 8 2007

Re: K070400

Trade/Device Name: LC Therapy, Model LCT-1000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 9, 2007 Received: February 12, 2007

Dear Mr. Devine:

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

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Page 2 - Mr. Neil E. Devine, Jr.

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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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# Indication For Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

LC Therapy, Model LCT-1000 Device Name: _ _______________________________________________________________________________________________________________________________________________________________

#### Indications For Use:

LC Therapy, Model LCT-1000 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

______________________________________________________________________________________________________________________________________________________________________________

AND/OR

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

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