K-LASER

K120604 · Eltech S.R.L · ILY · May 25, 2012 · Physical Medicine

Device Facts

• Record ID: K120604
• Device Name: K-LASER
• Applicant: Eltech S.R.L
• Product Code: ILY · Physical Medicine
• Decision Date: May 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Each device 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

K-Laser Cube family (1, 2, 3, 4) are table-top infrared laser devices; emit coherent light in continuous or pulse modes at wavelengths 800nm, 905nm, and 970nm. Operated by clinicians; features touch screen interface for function management, handpiece for light delivery, and battery pack for portable use. Devices elevate tissue temperature via infrared energy; intended for temporary relief of minor muscle/joint pain, spasms, arthritis-related stiffness, and increased local blood circulation. Benefits include non-invasive pain management and muscle relaxation.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified against applicable FDA performance standards for electronic and light-emitting products.

Technological Characteristics

Table-top infrared laser; wavelengths 800nm, 905nm, 970nm; peak power 10W-20W. Continuous or pulse mode operation. Battery-powered or AC-powered. Includes touch screen interface, handpiece, and software-controlled emission. Conforms to 21 CFR 1010, 1040.10, and 1040.11.

Indications for Use

Indicated for patients requiring topical heating to relieve minor muscle/joint pain, muscle spasms, pain/stiffness from arthritis, promote muscle relaxation, and temporarily increase local blood circulation.

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-1200 (K091497)
• Laser-D68 (K061656)

Submission Summary (Full Text)

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MAY 2 5 2012

#### SUMMARY OF CTIVENESS

### SUBMITTED BY:

ELTECH s.r.l.

Via Castagnole, 20/H

31100 Treviso, Italy

Phone: [phone]

Fax: [phone]

### CONTACT:

## BE MANN UE CAEFIY A

#### Official Correspondent:

dr. Richard Albright

K-Laser USA

1185 W. Main Street, Franklin, TN 37064

Phone: [phone]

#### US Agent:

dr. Richard Albright ,PRES K-Laser USA 1185 W. Main Street, Franklin, TN 37064 Phone: [phone] Fax: [phone] Email: [e-mail]

#### DEVICE NAME (Trade/common, and classification): 1.

Proprietary name: K-LASER Common/usual name: K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 Classification name: Infrared Lamp Classification: Class II Regulation Nos.: 21 CFR 890.5500 Product Codes: ILY

.

": .

:

1-

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K120604
Page 2 of 3

#### PREDICATE DEVICES: 2.

SUBMISSION

The device under submission is substantially equivalent to the predicate devices:

K091497 (K-1200);

K061656 (Laser-D68);

The device under submission is a family of laser emit a beam of coherent light in either continuous wave or pulse mode at the following wavelengths:

K-Laser Cube 1: 905nm; peak power: 10W; K-Laser Cube 2: 800nm, 970nm; peak power: 15W; K-Laser Cube 3: 800nm, 905nm, 970; peak power: 20W; K-Laser Cube 4: 905nm; peak power: 10W.

# 3. PERFORMANCE STANDARDS: substantially equiv ser

The device conforms to the applicable requirements of 21 CFR section 1010 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products).

## 4. DESCRIPTION:

The devices under submission are a family of laser that emits a beam of coherent light in either continuous wave or pulse mode at the wavelengths previously described.

Each device is a table device, easy to transport, usable also without electrical net, thanks to a battery pack. It is composed of a touch screen for managing all the device functions, an emitter, an handpiece for the delivery of light, software and an on/off button to activate and deactivate the infrared emission.

ﺍﻟﺘﻲ ﺗ · '1'1' 1' 1' 11. 11 . . . . . re or pulse made at the wavelengths pre

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120604
Page 3 of

#### INTENDED USE/ INDICATIONS FOR USE: 5.

Each device 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.

#### SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: 6.

The devices under submission share the same intended use, similar design and functional features as the predicate devices without raising any issues of safety or effectiveness. Therefore, the devices under submission are substantially equivalent to the predicate devices K091497 (K-1200), K061656 (Laser-D68).

#### accard to contling chergy in the are 7. SAFETY AND EFFECTIVENESS: 1 , . .

There are no substantive differences between the product 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. They were developed and documented under Eltech's mature Quality Managerment System, under The Quality System Regulation, 21 CFR Part 820, under design/change control, and verified/validated to applicable standards/guidance documents.
RA ( C ) RA ( ( / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / Besides, Eltech's Quality Assurance System is certified by CERMET, notified body n. CE 0476, according to Annex II of 93/42 EEC Directive, transposed in Italy by Dlgs. n. 46 of 24 February 1997.

The devices are safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program.

.. , EFECTIVENESS: Date: 25th April 2012

Signature:

Francesco Zanata Eltech s.r.l. President

schily P.5Stardinge 57510111 15 Cell.

. : .

,

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is facing to the right, and its wings are curved upwards. The text is in all capital letters and is evenly spaced around the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Eltech S.R.L. % K-Laser USA Mr. Richard Albright President 1185 West Main Street Franklin, Tennessee 37064

2012 2 గ్రా

Re: K120604

Trade/Device Name: K-Laser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: IL Y Dated: February 28, 2012 Received: February 28, 2012

Dear Mr. Albright:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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### Page 2 - Mr. Albright

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Eunel Keith

r 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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## INDICATIONS FOR USE

## Indications for Use:

SECTION 4: STAT 1. KFT K-laser Cube 1,2,3, and 4 device 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 relaxationy?the\musple.tissue and to temporarily increase local blood circulation.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

........ relax.com of the muses

Neil R. Dale for mxm

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

510(k) Number K120604