The Electro-Light Therapy system is intended to be used alone or at the same time with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy when used with the transparent Electro-Light electrode.

Device Description

The Electro-Light Therapy offers similar infrared therapy to the K072256 predicate device. The IR Light covered by K072256 allowed the operation of only one light head. The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256. The Electro-Light Therapy device can shine its IR light through the optional transparent gel electrodes. The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode. The gel electrode was cleared under K072256. Like the predicate devices, the Electro-Light Therapy is intended to be used only by a qualified therapist. Both the predicate devices and the new device are intended to be used on a cart. The new device has a maximum time setting of 99 minutes.

AI/ML Overview

1. Table of acceptance criteria and the reported device performance

This 510(k) summary does not provide specific acceptance criteria or quantitative performance metrics in the format of a table. Instead, it relies on demonstrating substantial equivalence to predicate devices, particularly K072256 (HF 54 with Optional Hands-free operation) and K071445 (Terraquant Mq2000 V.5 With The Tq-1 Tens).

The primary performance aspects discussed the document relate to safety and intended use:

Acceptance Criteria (Implied)	Reported Device Performance
Safety - Temperature in Tissues(Maximum temperature in tissues below 45°C to prevent new safety issues compared to predicate)	"From Measurement, it was shown that the maximum temperature was 45 ℃ there is no new safety issue when compared with the K072256 predicate."
Safety - Patient Supervision(Prevention of patient falling asleep during treatment)	"The operator's manual requires that the operator remain in the same area as the patient and must monitor the patient to ensure that the patient has not fallen asleep."
Effectiveness/Functionality - Infrared Therapy Output(Similar IR therapy intensity to predicate K072256 for a single light head)	"The Electro-Light Therapy can support up to 4 light heads each with a similar intensity to the predicate K072256."
Effectiveness/Functionality - Combined Electrotherapy and IR Therapy(Ability to be used with legally marketed powered muscle stimulators, TENS units or Interferential Current Therapy through a transparent electrode, similar to K071445 for combined use.)	"The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode... The Electro-Light Therapy also has same characteristics of combined electrotherapy and IR therapy as the K071445 predicate."
Electrical Safety Standards(Compliance with relevant electrical safety standards, e.g., IEC 60601-1)	"The new device is in compliance to the same standards [as the predicate device]."

2. Sample size used for the test set and the data provenance

The document does not describe a formal study with a "test set" in the context of clinical performance or diagnostic accuracy. The evaluation appears to be based on:

Engineering/Bench Testing: The "Measurement" for tissue temperature (maximum temperature was 45 ℃) strongly suggests bench testing. There is no specified sample size for this test.
Comparison to Predicate Devices: The primary method of demonstrating substantial equivalence is by comparing the technological characteristics, performance capabilities (like light intensity and compatibility with electrodes), and safety features to legally marketed predicate devices.

Data Provenance: Not applicable as it's not a clinical study with patient data. The safety assessment relies on engineering measurements and a comparison of features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is an infrared therapy lamp. The 510(k) summary does not involve a "ground truth" derived from expert interpretation (e.g., radiologists interpreting images) for a test set. The evaluation focuses on physical characteristics, safety, and equivalence to existing devices.

4. Adjudication method for the test set

Not applicable. As there are no expert interpretations or clinical data in a formal test set described, there is no adjudication method mentioned.

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 is an infrared therapy lamp, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant to this submission.

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

Not applicable. This device is an infrared therapy lamp, not an algorithm or AI system.

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

For the "Temperatures in Tissues" section, the "ground truth" is established through physical measurement of temperature, likely using thermal sensors or similar instrumentation during testing. This is an objective physical measurement, not an expert consensus, pathology, or outcomes data.

For other aspects, substantial equivalence relies on:

Engineering specifications and design comparisons.
Compliance with recognized standards (e.g., IEC 60601-1).
Functional comparison to predicate devices, demonstrating similar intended use and performance.

8. The sample size for the training set

Not applicable. This device is an infrared therapy lamp and not an AI/ML device that requires a training set.

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

Not applicable. This device is an infrared therapy lamp and does not have a training set.

Summary

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IC090250

510(k) SUMMARY

For Hill Laboratories Electro-Light Therapy

FEB 1 1 2010

. . . .

1. Submitter's Name and Address

Submitter's Name:	Hill Laboratories
Address:	3 Bacton Hill Rd
City, State, and Zip:	Frazer, PA 19355

2. Contact Person

Name:	Brady Aller
Title:	Sales/Service Manager
Telephone:	(610) 644-2867
Facsimile:	(610) 647-6297
E-mail:	bradyaller@hilllabs.com

3, Manufacturing Facility Address

Manufacturer:	Hill Laboratories
Address:	3 Bacton Hill Rd
City, State, and ZIP:	Frazer, PA 19355

4. Establishment Registration Number

Establishment Registration Number: 2510425

5. Reason for Submission

Reason for Submission: New Device

6. Date of Summary Preparation

Date of Summary Preparation: January 26, 2009

7. Device Details

Proprietary or Trade Name: Electro-Light Therapy Infrared lamp Common Name:

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Device Common Name, Classification, Product Code & 8. CFR No.

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------LINER FOR AND AND ANDREn tranda12mm1	1-------------------------------------	1	------------------------------------890 5500

9. Classification Name

lamp, infrared, therapeutic heating

Device Classification Panel 10.

Physical Medicine

11. Indications for Use

Electro-Light Therapy System is used to provide topical heating for:

Temporary increases in local blood flow and circulation .
. Temporary relief of minor muscle and joint aches
. Temporary relief of pain and stiffness
. Relaxation of muscles
. Temporary relief (or relaxation) of muscle spasms
Temporary relief of minor pain and stiffness associated with arthritis .

Standards 12.

Mandatory Standards 12.1

There are no mandatory standards for the type of device contained in this 510(k).

12.2 Consensus Standards

The Electro-Light Therapy is designed to comply with the following Consensus Standards:

STANDARD NO.	TITLE
IEC 60601-1 +A1, +A2	Medical Electrical Equipment- Part 1: General Requirements forSafety

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13. Predicate Devices

510(k) Number	Trade or Proprietary or ModelName	Manufacturer	Class
K072256	HF 54 with Optional Hands-freeoperation	Hill Laboratories	2
K071445	Terraquant Mq2000 V.5 WithThe Tq-1 Tens	Medical QuantLTD.	2

Substantial Equivalence (SE) Rationale 13.1

13.1.1 Technology

The significant difference between the Electro-Light Therapy device and the Terraquant Mg2000 V.5 With the Tq-1 Tens is that the predicate device K071445 is equipped with an on-board TENS stimulator. The Electro-Light Therapy device does not have a built-in TENS stimulator.

The Electro-Light Therapy device can shine its IR light through the optional transparent gel electrodes. In the case of the predicate K071445, the electrode is an annular gel electrode ring attached to the front of the IR applicator and light can shine through the middle of the electrode ring. The Electro-Light Therapy is intended be used with any legally marketed TENS, interferential, or powered muscle stimulator. The IR and visible light will pass through a clear gel electrode. The gel electrode was cleared under K072256. Like the predicate devices, the Electro-Light Therapy is intended to be used only by a qualified therapist.

Both the predicate devices and the new device are intended to be used on a cart.

13.1.2 Standards

The Electrical Safety of the predicate device is consistent with FDA guidance and international standards. The new device is in compliance to the same standards.

13.1.3 Materials

The materials used in construction of the device, including the patient contacting parts and the method of information display are similar to the predicate cleared under .

13.1.4 Measured Parameters

The measured parameters for the proposed Electro-Light Therapy are the similar to those displayed on the device cleared under K072256.

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13.1.5 Risk Analysis

The primary risks were identified as:

. Temperatures in tissues above 45 °C
. Patient falling asleep during treatment

Temperatures in Tissues 13.1.5.1

From Measurement, it was shown that the maximum temperature was 45 ℃ there is no new safety issue when compared with the K072256 predicate.

13.1.5.2 Patient falling asleep during treatment

The operator's manual requires that the operator remain in the same area as the patient and must monitor the patient to ensure that the patient has not fallen asleep.

The primary difference between the new device and the predicate K072256 is that the predicate has a setting that allows continuous IR output whereas the new device has a maximum time setting of 99 minutes. This is not considered to be significant.

13.2 Conclusion

The proposed Electro-Light Therapy when used as directed in the operator's manual presents no new safety or effectiveness concerns and is Substantially Equivalent to the IR therapy hand-piece cleared under K072256. The Electro-Light Therapy also has same characteristics of combined electrotherapy and IR therapy as the K071445 predicate.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Hill Laboratories % Mr. Brady Aller 3 Bacton Hill Road Frazer, PA 19355

Re: K090250

Trade/Device Name: Electro-Light Therapy Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: II Product Code: ILY Dated: February 2, 2010 Received: February 3, 2010

FEB 1 1 2010

Dear Mr. Aller:

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.

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.

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Page 2 - Mr. Brady Aller

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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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 statement

510(k) No. If known

Device Name:

Electro-Light Therapy

Indications For Use:

Electro-Light Therapy System is used to provide topical heating for:

Temporary increases in local blood flow and circulation .
. Temporary relief of minor muscle and joint aches
. Temporary relief of pain and stiffness
. Relaxation of muscles
. Temporary relief (or relaxation) of muscle spasms
. Temporary relief of minor pain and stiffness associated with arthritis

Prescription Use X (Per 21 CFR 801 Subpart D

Over-The-Counter Use

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation

AND/OR

luation (ODE)
FOR M.MEIKARS
Division Sign-Off

Division of Surgical, Orthopedic, 2 .d Restorative Devices

5 : 9(k) Number

Number K090250

Electro-Light Therapy 510(k)

January 26, 2009

Section 4-1

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.