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 Description

Klaser is an infrared therapy device, composed of emitter, software, probe for the delivery of light and an on/off button to activate and deactivate the infrared emission.

AI/ML Overview

The provided documentation for the K-Laser Heat Lamp (K050070) does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices.

Here's an breakdown based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Performance Standards: Conforms to 21 CFR section 1010.10 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products).	"Klaser conforms to the applicable requirements of 21 CFR section 1010.10 (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products)." (From Section E, Part 3)
Intended Use/Indications For Use: - Temporary increase in local blood circulation - Temporary relief of minor muscles and joint aches, pains and stiffness - Relaxation of muscles - Muscle spasms - Minor pain and stiffness associated with arthritis	"The intended Use/Indications For Use stated herein are identical to the cleared indications for the predicate device." (From Section E, Part 5) The K-Laser generates infrared therapy for treatment and shares the same or similar basic characteristics and the same intended use as predicate devices. (From Section E, Part 6)
Safety and Effectiveness: No substantive differences between K-Laser and predicate devices or other similar medical devices. Developed and documented under Eltech's mature Quality Management System (21 CFR Part 820), under design/change control, and verified/validated to applicable standards/guidance documents. Certified by CERMET (notified body n. CE 0476) according to Annex II of 93/42 EEC Directive.	"There are no substantive differences between the products defined in SHE EPT This 2011 - 1 in other similar medical devices. They were developed and documented under Eltech's mature Quality Management 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. Klaser is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program." (From Section E, Part 7)

Summary of Device Performance: The primary claim of performance is that the K-Laser functions identically to established predicate devices (ALT Laser, Model VTR 75; Vectra Genisys Laser System; Solaris D890) for the specified indications for use, and it adheres to relevant electrical and light-emitting product performance standards and quality system regulations. There is no specific performance data presented in terms of efficacy metrics (e.g., how much pain reduction, how much blood circulation increase). The "performance" is implicitly deemed acceptable because it directly mirrors that of already cleared devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

None provided. The document does not describe a clinical study with a test set of patients or data. The submission relies on substantial equivalence to predicate devices, not de novo clinical testing for performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set or ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for an infrared therapy device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device. Its "performance" is its ability to emit infrared radiation for therapeutic purposes, which is demonstrated by its technical specifications and compliance with standards, and its similarity to predicate devices already cleared for similar applications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly defined as "ground truth" in the context of a new study. The "ground truth" for the K-Laser's safety and effectiveness relies on the prior clearance of its predicate devices and its adherence to established performance standards for electronic and light-emitting products. The manufacturer also highlights their robust Quality Management System.

8. The sample size for the training set

Not applicable. This device is not developed using machine learning or AI models with training sets.

9. How the ground truth for the training set was established

Not applicable. This device is not developed using machine learning or AI models with training sets.

Summary

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510(K) K-LASER HEAT LAMP Nº 9067781 SECTION E: 510 (K) STATEMENT OR SUMMARY

050070 1 of 2

MAR 2 5 2005

SUMMARY OF SAFETY AND EFFECTIVENESS

UBMITTED BY: ELTECH s.r.l.

Via Castagnole, 20/H 31100 Treviso Italy Phone: 0039 422 210 430 Fax: 0039 422 297 137

I DEVICE NAME (Trade/common, and classification): Klaser Therapy Probe.

Classification: Class II Regulation Nos.: 890.5500 Product Codes: ILY

2. PREDICATE DEVICES:

ALT Laser, Model VTR 75 - Cleared under K031613 Vectra Genisys Laser System - Cleared under K 040662 Solaris D890 - Cleared under K040729

PERFORMANCE STANDARDS: Klaser conforms to the applicable requirements of 21 CFR section 1010 న. (Performance Standards for Electronic Products: General) and 21 CFR sections 1040.10 and 1040.11 (Performance Standards for Light-Emitting Products).
DESCRIPTION: Klaser is an infrared therapy device, composed of emitter, software, probe for the delivery ঞ্চ of light and an on/off button to activate and deactivate the infrared emission.

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510(K) K-LASER HEAT LAMP Nº 9067781 SECTION E: 510 (K) STATEMENT OR SUMMARY

K050070 2 of 2

INTENDED USE/ INDICATIONS FOR USE: Klaser provides infrared therapy for the following allowed 5 claims:
Infrared therapy to provide topical heating for:
Temporary increase in local blood circulation -
Temporary relief of minor muscles and joint aches, pains and stiffness -
Relaxation of muscles .
Muscles spasms ﺘ
Minor pain and stiffness associated with arthritis -

'he intended Use/Indications For Use stated herein are identical to the cleared indications for the predictae levice.

SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: K-Laser generates infrared therapy for treatment of , o GBC PANY Williams and shares the same or similar basic characteristics and the same intended sciouralized the proposed K-Laser is substantially equivalent to the Solans ass as the products
D890, cleared under K040729; to ALT Laser Model VTR 75, deared under K031612; to Vectra Genisys Laser System, cleared under K04066.
1. SAFETY AND EFFECTIVENESS: There are no substantive differences between the products defined in SHE EPT This 2011 - 1 in other similar medical devices. They were developed and documented under Eltech's mature Quality m other of million.
  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. Klaser is safe and effective when used as indicated in specific applications under a clinician's supervision/therapy program.

Signed:__.

Fitechs r.l. rancesco Zanata President

Date: 12-7-2004

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human face in profile, composed of three curved lines.

Public Health Service

MAR 2 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Eltech s.r.l. c/o Mr. Richard Albright Laser Therapy Products 1510 Towne Park Lane Franklin, Tennessee 37067

Re: K050070

Trade/Device Name: Klaser Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: February 18, 2005 Received: February 22, 2005

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. Iisting 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. I'l // 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 nust 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 - Mr. Richard Albright

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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) K-LASER HEAT LAMP Nº 9067781 SECTION D: STATEMENT OF INDICATION FOR USE

INDICATIONS FOR USE

K050070

510(k) Number (if known):

Device Name: KLASER

Indications for Use:

Prescription Use X (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)

Muriam C. Provost

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

510(k) Number K650070

D - Page 1 of 1

Regulation Number and Section

§ 890.5500 Infrared lamp.

(a)
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.(b)
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.