Red and infrared light to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, strains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Description

The Applied BioPhotonics® Phototherapy System ABPT1003 is a light therapy device using specific wavelengths of polychromatic energy produced by super-luminous light emitting diodes (LEDs) to treat a variety of skin and body conditions.
The device can be described as a Class II Low Level Light treatment process employing the application of light and heat, which penetrates the skin surface to the underlying tissues, triggering normal cellular functions. This technology is commonly referred to as photobiostimulation, light emitting diode therapy (LEDT), LLLT, or LED's. The application of LED's to tissue is non-invasive.
Using patent pending and proprietary techniques and computational processes, the Applied BioPhotonics® Phototherapy System ABPT1003 is composed of:

Proprietary hardware (i.e. ABLM1002 LightMachine)
LightOS software (running in the LightMachine)
LightPad sets (ABLP103) comprising flexible, aseptic, polymeric LED pads
Cables (for connecting LightPads and LightMachines)
The IR and red spectrum emitted from LEDs in the ABLP103 LightPad sets is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, strains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The LightMachine control panel displays to the operator what treatment is being performed and provides the user with a choice of driving one or two LightPad sets with any chosen treatment protocol.
The software component of the device controls the user's selection of specific treatment protocols on the LightMachine's control panel. The treatment may be set manually by entering LED-operating conditions (i.e. wavelength, duration, and pulse frequency) or by selecting preset treatment protocols. The software is revision-controlled and can be upgraded by the manufacturer.
This is a prescription use only device. The labeling, instructions and user operations are designed for health care professionals.

AI/ML Overview

This document is a 510(k) Summary for the Applied BioPhotonics® Phototherapy System ABPT1003. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study proving the device meets specific performance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not explicitly detailed in this type of submission.

Based on the provided text, here's what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance

The document states that "All the test results demonstrate that Applied BioPhotonics Phototherapy System ABPT1003 meets the requirements of its predefined acceptance criteria and intended uses." However, the specific acceptance criteria are not explicitly listed or quantified in the provided text.

The "reported device performance" is essentially that the device passed various safety and compatibility tests, and is substantially equivalent to predicate devices. No quantifiable performance metrics for "efficacy" (e.g., specific pain reduction percentages, increase in blood circulation metrics) are provided from a clinical study for this device.

Acceptance Criteria	Reported Device Performance
Compliance with Electromagnetic Compatibility Standards (e.g., IEC 60601-1-2)	Demonstrated compliance with international standards for electromagnetic compatibility. (Specific performance values not detailed, but stated as "meets the requirements").
Compliance with Electrical Safety Standards (e.g., IEC 60601-1)	Demonstrated compliance with international standards for electrical safety. (Specific performance values not detailed, but stated as "meets the requirements").
Compliance with Photobiological Safety Standards (e.g., IEC 62471)	Demonstrated compliance with international standards for photobiological safety. (Specific performance values not detailed, but stated as "meets the requirements").
Compliance with Software Life Cycle Processes Standards (e.g., IEC 62304)	Demonstrated compliance with international standards for medical device software life cycle processes. (Specific performance values not detailed, but stated as "meets the requirements").
Substantial Equivalence to Predicate Devices (in intended use, fundamental scientific technology, and technological characteristics)	Analysis of performance data (bench and safety testing) demonstrates that the device is as safe and effective as, and therefore substantially equivalent to, the listed predicate devices (IllumiMed™, LIGHTWAVE Professional Deluxe, LumiWave 1X4 Infrared Therapy Device, HealthLight™ MicroController, MiniPro, ProNeuroLight and Pro Unit).

Additional Requested Information:

Sample sizes used for the test set and the data provenance:
- Test set sample size: Not applicable/not stated. The non-clinical testing appears to refer to engineering verification and validation testing of the device itself (e.g., EMC, electrical safety, software V&V) rather than a clinical "test set" of patients.
- Data provenance: The document mentions "All laboratory tests and measurements were performed by an independent test lab certified to make such assessments." The country of origin for this testing is not specified, but the device submitter is from Hong Kong, China SAR. The testing is non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was primarily non-clinical engineering and software testing. Ground truth in the context of clinical expert review is not relevant here.
Adjudication method for the test set:
- Not applicable as no clinical test set requiring expert adjudication is described.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
- No MRMC clinical comparative effectiveness study was done. The device is a phototherapy system, not an AI diagnostic tool that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- While software verification and validation were performed, this relates to the device's operational software and controls, not an AI algorithm performing a specific diagnostic or clinical task. The "standalone performance" of the device is demonstrated by its compliance with safety and technical standards as an independent medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" would be established by the specifications and standards the device was designed to meet (e.g., specific voltage tolerances, current levels, electromagnetic emissions limits, software functional requirements). It's based on engineering specifications and regulatory standards. No clinical ground truth (like pathology or outcomes data) was used or required for this type of submission.
The sample size for the training set:
- Not applicable. This device does not incorporate machine learning or AI that requires a "training set" in the conventional sense of data-driven model training.
How the ground truth for the training set was established:
- Not applicable, as there was no training set for an AI algorithm.

Summary

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

January 7, 2015

Applied BioPhotonics, Ltd. % Ms. Roshana Ahmed OptumInsight (Canada) Incorporated 4 Innovation Drive Dundas, Ontario L9H 7P3 CANADA

Re: K142256

Trade/Device Name: Applied BioPhotonics® Phototherapy System ABPT1003 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp, Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ILY Dated: December 17, 2014 Received: December 18, 2014

Dear Ms. Ahmed:

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

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Page 2 - Ms. Roshana Ahmed

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142256

Device Name

Applied BioPhotonics® Phototherapy System ABPT1003

Indications for Use (Describe)

Applied BioPhotonics® Phototherapy System ABPT1003 is intended to provide phototherapeutic light to the body. The device emits:

Red and infrared light to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Preparation Date:	December 16, 2014
Submitter:	Applied BioPhotonics Ltd.
Address:	15th Floor, Far East Consortium Building 121 DeVoeux Road, Central, Hong Kong, China SAR
Phone:	+886-3-621-8538
Fax:	+886-3-668-3089
Contact:	Eric Hsieh(erichsieh@appliedbiophotonics.com)
Identification of the Device:
Proprietary/Trade name:	Applied BioPhotonics® Phototherapy SystemABPT1003
Classification Name:	Lamp, Infrared, Therapeutic HeatingPowered Laser Surgical Instrument
Device Classification:	II
Regulation Number:	890.5500878.4810
Panel:	Physical MedicineGeneral & Plastic Surgery
Product Code:	ILYGEX

Predicate Devices

Substantial equivalence is claimed to the following devices as related to intended use, design, and technological characteristics:

IllumiMed™, PhotoActif, LLC, K060792 ●
LIGHTWAVE Professional Deluxe, LIGHTWAVE Technologies LLC, K082586 .
LumiWave 1X4 Infrared Therapy Device, BioCare Systems, Inc., K051816
HealthLight™ MicroController, MiniPro, ProNeuroLight and Pro Unit, . BioRemedi Therapeutic Systems, Inc., K101894

Description of the Device

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Applied BioPhotonics Ltd. Traditional 510(k)

The device can be described as a Class II Low Level Light treatment process employing the application of light and heat, which penetrates the skin surface to the underlying tissues, triggering normal cellular functions. This technology is commonly referred to as photobiostimulation, light emitting diode therapy (LEDT), LLLT, or LED's. The application of LED's to tissue is non-invasive.

Using patent pending and proprietary techniques and computational processes, the Applied BioPhotonics® Phototherapy System ABPT1003 is composed of:

Proprietary hardware (i.e. ABLM1002 LightMachine) ●
LightOS software (running in the LightMachine)
. LightPad sets (ABLP103) comprising flexible, aseptic, polymeric LED pads
. Cables (for connecting LightPads and LightMachines)

The IR and red spectrum emitted from LEDs in the ABLP103 LightPad sets is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, strains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The LightMachine control panel displays to the operator what treatment is being performed and provides the user with a choice of driving one or two LightPad sets with any chosen treatment protocol.

The software component of the device controls the user's selection of specific treatment protocols on the LightMachine's control panel. The treatment may be set manually by entering LED-operating conditions (i.e. wavelength, duration, and pulse frequency) or by selecting preset treatment protocols. The software is revision-controlled and can be upgraded by the manufacturer.

This is a prescription use only device. The labeling, instructions and user operations are designed for health care professionals.

Intended Use/Indications for Use

Applied BioPhotonics® Phototherapy System ABPT1003 is intended to provide phototherapeutic light to the body. The device emits:

Red and infrared light to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, sprains, strains, and muscle spasm, as well as back, neck and shoulder pain; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

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Technological Characteristics

The Applied BioPhotonics® Phototherapy System ABPT1003 employs pulsed LED of the same wavelengths as the predicate devices for the same indicated uses, yet provides the user with a greater degree of independent control of each set of LightPads, as well as greater flexibility in setting, sequencing, and monitoring the LED pulse conditions (wavelength, duration, pulse frequency) before and during treatments.

Applied BioPhotonics® Phototherapy System ABPT1003 affords added safety over the predicate devices with an integral hardware safety timer, AC socket with inline fuse and mechanical off switch, universal input power supply (capable of safely operating at 120VAC or 240VAC inputs).

Based on the comparison table below, the proposed device is substantially equivalent to the predicate devices in intended use, safety and performance claims.

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Item	Proposed device	Predicate device	Predicate device	Predicate device	Predicate device
	Applied BioPhotonics®Phototherapy SystemABPT1003	illumiMed™	LIGHTWAVE ProfessionalDeluxe	LumiWave 1X4 InfraredTherapy Device	HealthLight™MicroController,MiniPro,ProNeuroLight andPro Unit
510(k) Number	Interchangeable Pads	K060792	K082586	K051816	K101894
LED	Interchangeable Pads	Interchangeable Pads &Wands	Interchangeable Panels	LED Strap (Faceplate)	InterchangeablePanels
Power	120-230VAC, switched,fused	120VAC, switched	120VAC	120VAC	120VAC
Software	Upgradeable, RevisionControlled	Upgradable	Fixed	Fixed	Fixed
User Control	LCD Panel, SelectTreatment (Program),Preset or Manual LEDSettings, Automatic LEDSequencing Capable,Independent Control andMonitoring of Each Setof LightPads	Control Panel, SelectProtocol (Program), PresetLED Settings, AutomaticLED Sequencing Capable	LCD & keyboard, SelectFunction, Preset LEDSettings	High / Low Select, PresetLED Settings	Control Panel, SelectProtocol (Program),Preset LED Settings,Automatic LEDSequencing Capable
LED PulseFrequencies	Multiple	Multiple	Multiple	Single	Multiple
LEDWavelengths	630nm red850nm NIR	430nm blue660nm red940nm NIR	N/S blue630nm red830nm NIR	880nm NIR	430nm blue630nm red880nm NIR
Safety Timer	Yes	No	No	No	Yes
Pad Surface	Flexible Pads - Non-Porous	Flexible Pads – Porous	Rigid Pad – Non-PorousFlexible Pads - Porous	Rigid Pad – Non-Porous	Flexible Pads - VeryPorous

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Non-Clinical Testing

A series of studies were performed to assess the safety and effectiveness of the Applied BioPhotonics® Phototherapy System ABPT1003 including:

Electromagnetic compatibility tests
Electrical safety tests ●
. Software verification and validation

Testing was done in compliance with standards including, but not limited to, the following:

. IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements . for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests
. IEC 62471 Photobiological Safety of Lamps and Lamp Systems
. IEC 62304 Medical device software – Software life cycle processes

All laboratory tests and measurements were performed by an independent test lab certified to make such assessments. All the test results demonstrate that Applied BioPhotonics Phototherapy System ABPT1003 meets the requirements of its predefined acceptance criteria and intended uses.

Clinical Testing

Clinical test data is not required to support the safety and effectiveness of this device.

Conclusion

The Applied BioPhotonics® Phototherapy System ABPT1003 has similar intended use, similar fundamental scientific technology, and similar technological characteristics with the predicate devices. Analysis of performance data including bench and safety testing data demonstrates that the Applied BioPhotonics® Phototherapy System ABPT1003 is as safe and effective as, and is therefore, substantially equivalent to, the predicate devices.

Regulation Number and Section

N/A