The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Device Description

The proposed device, RED Light Device is a battery operated device that uses low power light spectrum at red and infrared LED, at wavelength of 633 ±5nm, 830 ±5nm emitting optical power in a uniform distribution with no hot spots.

The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C. charging adapter.

It is a hand held light emitting diode (LED) device for the treatment of periorbital wrinkles designed for home-use.

The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.

AI/ML Overview

The provided text is a 510(k) summary for the "RED Light Device," seeking FDA clearance based on substantial equivalence to a predicate device. It does not describe a clinical study designed to prove the device meets specific acceptance criteria in the way an AI/ML device would be evaluated. Instead, it focuses on non-clinical tests to demonstrate safety and performance equivalence to a previously cleared device.

Therefore, many of the requested categories for AI/ML device evaluation (like acceptance criteria for performance metrics, ground truth establishment for a test set, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an algorithm) are not applicable to this submission, as it's for a light therapy device.

Here's a breakdown of the information that is available, reframed to address your request where possible, and clearly indicating what is not present in the document given its nature:

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

The document frames "acceptance criteria" and "performance" in terms of equivalence to the predicate device and compliance with established safety standards, rather than performance against a clinical efficacy target metric.

Acceptance Criteria Category	Reported Device Performance / Compliance
Product Code	OHS (Substantially Equivalent to Predicate)
Regulation No.	21 CFR 878.4810 (Substantially Equivalent to Predicate)
Class	2 (Substantially Equivalent to Predicate)
OTC use	Yes (Substantially Equivalent to Predicate)
Indication for Use	To emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles (Substantially Equivalent to Predicate)
Handheld	Yes (Substantially Equivalent to Predicate)
Contacting Materials	ABS & Stainless Steel (Substantially Equivalent to Predicate)
Measurement Wavelength	Red: 633 ±5nm; Infrared: 830 ±5nm (Substantially Equivalent to Predicate)
Light Source	Light Emitting Diode (LED) (Substantially Equivalent to Predicate)
Waveform	Constant (Substantially Equivalent to Predicate)
Energy Source	25 LEDs over 17 cm² (Substantially Equivalent to Predicate)
Power Density	125 mW/cm² (70 mW/cm² (633 nm); 55 mW/cm² (830 nm)) (Substantially Equivalent to Predicate)
Power Supply	Adaptor: 100~240V AC 50/60Hz; Lithium battery: 2x3.7V (Substantially Equivalent to Predicate)
Initial Treatment Course	For the first month (4 weeks), treatment should be performed 3 times a week for 15-20 minutes each time (5-7 minutes on each treatment zone). (Substantially Equivalent to Predicate)
Electrical Safety	Complies with IEC 60601-1, IEC 60601-1-11, IEC 62471, IEC 60601-2-57 (Substantially Equivalent to Predicate for those shared, and additional compliance for proposed device)
EMC	Complies with IEC 60601-1-2 (Substantially Equivalent to Predicate)
Biocompatibility	Complies with ISO 10993-1 (Substantially Equivalent to Predicate). Specifically, ISO 10993-5 (In Vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) were tested.
Usability/Label Comprehension	100% of 35 participants correctly self-selected, demonstrated setup, light sensitivity test, operation, and cleaning. 95% correctly answered each questionnaire question. (This acts as a performance metric for user understanding and safe use).

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

Test Set Sample Size: For the Usability/Label Comprehension Study, the sample size was 35 participants.
Data Provenance: The document does not specify the country of origin for the usability study participants. It's a prospective study for usability.
For demonstrating technical compliance (e.g., electrical safety, EMC, biocompatibility): These tests are typically performed on samples of the device itself by accredited labs. The "sample size" here refers to the number of devices tested, which isn't specified but generally follows standard testing protocols for device certification.

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 in the context of clinical efficacy experts determining ground truth for a diagnostic AI.
For the Usability/Label Comprehension study, the "ground truth" was whether participants could correctly perform tasks and answer questions based on the instructions, which was assessed directly by the study design, not by external experts establishing a clinical ground truth.

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

Not applicable as there is no clinical test set requiring adjudication for ground truth.
For the usability study, the performance criteria (e.g., 100% correctly demonstrated setup) are objective and do not require expert adjudication in the manner of medical image interpretation.

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

No, a MRMC comparative effectiveness study was not done. This device is a direct-to-consumer light therapy device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. The "RED Light Device" is a physical light therapy device, not an algorithm. Its performance is inherent in its physical output and user interaction, not in standalone algorithmic interpretation.

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

Not applicable for clinical efficacy as no clinical study was conducted.
For Usability: The "ground truth" was successful completion of prescribed tasks and correct answers to questionnaire items as defined by the study protocol related to understanding device operation and safety.

8. The sample size for the training set

Not applicable. This device does not use machine learning, therefore there is no "training set."

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

Not applicable. As there is no training set for a machine learning algorithm, ground truth establishment for a training set is irrelevant.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or movement. The profiles are arranged in a way that they appear to be connected. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

January 13, 2017

Zhongshan Bisen Plastic Electronic Products Co., Ltd. c/o Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No. 25 BanBiDian Rd. LiYuan Town, TongZhou District, Beijing 101121 China

Re: K162489

Trade/Device Name: RED Light Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHS Dated: December 2, 2016 Received: December 7, 2016

Dear Mr. Wang:

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

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Page 2 - Mr. Ray Wang

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 (OS) 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/ResourcesforYou/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,

Jennifer R. Stevenson -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K162489

Device Name

RED Light Device

Indications for Use (Describe)

The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Tab #7 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __

1. Date of Preparation
  08/23/2016
Sponsor 2.

Zhongshan Bisen Plastic Electronic Products Co.,Ltd.

2/F,Building1,No.81,Dongzhen North Road,Zhangjiabian 1st village,Torch Development Zone,Zho ngShan City,GuangDong,China Establishment Registration Number: Not yet registered or the Number Contact Person: FengPing Li Position: General Manager Tel: 86-760-88297142 Fax:86- 760-88297142 Email: binzim@163.com

Submission Correspondent 3.
Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd.

5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: +86-21-50313932 Fax: +86-21-68093116 Email: ray.wang@believe-med.com

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4. Identification of Proposed Device

Trade Name: RED Light Device Common Name: Light Emitting Diode (LED) Device Model(s): BZ-0606

Regulatory Information:

Classification Name: Light Based Over The Counter Wrinkle Reduction Classification: II; Product Code: OHS; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;

Indication for Use Statement:

The RED Light Device is an OTC device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Device Description 5.

The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C. charging adapter.

It is a hand held light emitting diode (LED) device for the treatment of periorbital wrinkles designed for home-use.

The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.

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6. Identification of Predicate Device

Predicate 510(k) Number: K152332 Product Name: Perfectio LED Infrared Device Manufacturer: OMM IMPORTS INC DBA ZERO GRAVITY

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:2012, Medical electrical equipment-Part 1: General requirements for basic safety, and essential performance.

IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

IEC 60601-2-57:2011, Medical electrical equipment - Part 2-57: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.

IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for medical device equipment and medical electrical systems used in the home healthcare environment.

IEC 62471:2006 , Photobiological Safety of lamps and lamp systems.

ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

Performance Test: Temperature Test

A Usability/Label Comprehension Study was conducted with 35 participants.

The results of the study showed that (100%) were able to:

-Correctly self-select as being an appropriate user of the device.

-Correctly demonstrate how to set up the device, perform the Light Sensitivity Test, operate the device (apply Tx), and clean the device.

And that (95%) of participants were able to correctly answer each question for the Questionnaire portion of the Study.

Clinical Test Conclusion 8.
Clinical data was not included in this submission.

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9. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device	Remark
Product Code	OHS	OHS	SE
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	SE
Class	2	2	SE
OTC use	Yes	Yes	SE
Indication forUse	The RED Light Device is an OTC deviceindicated to emit energy in the red and IRregion of the spectrum for use indermatology for the treatment ofperiorbital wrinkles.	Perfectio LED infrared device is anover the counter device indicated toemit energy in the red and IR regionof the spectrum for use indermatology for the treatment ofperiorbital wrinkles.	SE

Table 1 General Comparison

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ITEM	Proposed Device	Predicate Device	Remark
Handheld	Yes	Yes	SE
ContactingMaterials	ABS & Stainless Steel	ABS & Stainless Steel	SE
Measurementwavelength	Red: 633 ±5nmInfrared: 830 ±5nm	Red: 633 ±5nmInfrared: 830 ±5nm	SE
Light Source	Light Emitting Diode (LED)	Light Emitting Diode (LED)	SE
Waveform	Constant	Constant	SE
Energy Source	25 LEDs over 17 cm²	25 LEDs over 17 cm²	SE
Power Density	125 mW/cm270 mW/cm2 (633 nm); 55 mW/cm2 (830 nm)	125 mW/cm270 mW/cm2 (633 nm); 55 mW/cm2 (830 nm)	SE
Power Supply	Adaptor: 100~240V AC 50/60HzLithium battery: 2x3.7V	Adaptor: 100~240V AC 50/60HzLithium battery: 2x3.7V	SE
Initial TreatmentCourse	For the first month (4 weeks), treatmentshould be performed 3 times a week for15-20 minutes each time.(5-7 minutes oneach treatment zone).	For the first month (4 weeks), treatmentshould be performed 3 times a week for15-20 minutes each time.(5-7 minutes oneach treatment zone).	SE
MaintenanceRegime	Individuals with periorbital lines andwrinkles	Individuals with periorbital lines andwrinkles	SE

Table 2 Performance Comparison

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ITEM	Proposed Device	Predicate Device	Remark
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	SE
	Comply with IEC 60601-1-11	Comply with IEC 60601-1-11
	Comply with IEC 62471	Comply with IEC 62471
	Comply with IEC 60601-2-57	/
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	SE
Label and	Conforms to FDA Regulatory	Conforms to FDA Regulatory	SE
Labeling	Requirements	Requirements
Level of Concern	Moderate	Moderate	SE
of the Software

Table 3 Safety Comparison

10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.