K-LASER K-1200, MODEL 12 W

K091497 · Eltech S.R.L · ILY · Aug 19, 2009 · Physical Medicine

Device Facts

• Record ID: K091497
• Device Name: K-LASER K-1200, MODEL 12 W
• Applicant: Eltech S.R.L
• Product Code: ILY · Physical Medicine
• Decision Date: Aug 19, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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-1200 is a portable infrared therapy table device; battery-powered or electrical net operation. Components include touch screen interface, infrared emitter, and handpiece for light delivery. Clinician operates device to deliver infrared energy to patient tissue. Output is topical heating; intended to elevate tissue temperature. Clinical benefit includes temporary relief of minor muscle/joint pain, muscle spasm, arthritis-associated pain/stiffness, muscle relaxation, and increased local blood circulation.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological similarities to predicate devices and adherence to performance standards for light-emitting products.

Technological Characteristics

Infrared therapy device; portable table-top form factor; battery or AC powered. Includes touch screen control, infrared emitter, and handpiece. Conforms to 21 CFR 1010, 1040.10, and 1040.11 performance standards for light-emitting products.

Indications for Use

Indicated for patients requiring topical heating for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, muscle relaxation, and temporary increase in 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-LASER (K050070)
• LCT-1000 (K070400)

Submission Summary (Full Text)

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3

510(K) Premarket SUBMISSION

510(K) K-1200 HEAT LAMP SECTION_5: STATEMENT OF SUMMARY

Rev. 0 Sec. 5 Page 1 of

# SUMMARY OF SAFETY AND EFFECTIVENESS

#### · SUBMITTED BY:

AUG 1 9 2009

ELTECH s.r.i.

Via Castagnole, 20/H 31100 Treviso, Italy Phone: [phone]

Fax: [phone]

# CONTACT:

#### Official Correspondent:

dr. Richard Albright K-Laser USA 311 So. Royal Oaks Blvd Suite 140-A Franklin, TN 37064 Phone: [phone]

#### US Agent:

dr. Richard Albright ,PRES K-Laser USA 311 So. Royal Oaks Blvd 140-A Franklin, TN 37064 Phone: [phone] Fax: [phone] Email: [e-mail]

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

Proprietary name: K-LASER Common/usual name: K-1200 Classification name: Therapy Probe. Classification: Class II Regulation Nos.: 890.5500 Product Codes: ILY

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# 510(K) PREMARKET SUBMISSION

## 510(K) K-1200 HEAT L SECTION 5: STATEMENT OF SUMMARY

Rev. . O Sec. 5 Page

## 2. PREDICATE DEVICES:

K-LASER - Cleared under K050070 LCT-1000 – Cleared under K070400

# 3. PERFORMANCE STANDARDS:

K-1200 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:

K-1200 is an infrared therapy 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.

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

The 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.

The intended Use/Indications For Use stated herein are identical to the cleared indications for the predicate device.

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

K-1200 generates infrared therapy for treatment of selected medicals conditions and shares the same basic characteristics and the same intended use as the predicate device. Therefore, the proposed device is substantially equivalent to the K-LASER, cleared under K050070 and LCT-1000, cleared under K070400.

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K09149

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510(K) Premarket SUBMISSION

510(K) K-1200 HEAT LAMP SECTION 5: STATEMENT OF SUMMARY

Rev. 0 Sec. 5 Page 3

#### 7. SAFETY AND EFFECTIVENESS:

There are no substantive differences between the product defined in this 510(k) submission and the predicate device. 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. 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 DIgs. n. 46 of 24 February 1997.

K-1200 is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program.

Signed:***_***_ and the signature of Elizabeth Jackson

Eltech s.r.l. Francesco Zanata President

Date: 14 May, 2009

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white.

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

Eltech s.r.l % K-Laser USA Dr. Richard Albright 311 So. Royal Oaks Boulevard Suite 140-A Franklin, Tennessee 37064

Re: K091497

AUG 1 9 2009

Trade/Device Name: K-1200 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: July 2, 2009 Received: July 21, 2009

Dear Dr. 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.

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

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Page 2 - Dr. Richard Albright

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

ely yours,
F/L

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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KU91497

510(K) Premarket SUBMISSION

510(K) K-1200 HEAT LAMP SECTION_4: STATEMENT OF INDICATION FOR USE

# INDICATIONS FOR USE

Device Name: K-1200

#### Indications for Use:

The 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.

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)

Niel Reber for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091497

510(K) Submission