The Oren LED Perioral Light Therapy System (Model: OR-01) is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.

Device Description

The Oren LED Perioral Light Therapy System (Model: OR-01) is an over-the counter light emitting diode (LED) device that emits energy for use in dermatology for treatment fine lines and wrinkles, and increase in circulation within the perioral region. The device contains four types of LEDs: 605nm amber, 630m red, 660nm red, and 880nm infrared.

The Oren LED Perioral Light Therapy System components include the main device, Charging base, power cord, adapter. There are two buttons on the top edge of the main unit, Power button and Shutdown button. This device Only has one treatment modes.

The Oren LED Perioral Light Therapy System is applied directly to the skin to ensure consistent administration of light during each treatment. The device is sold as Over the Counter (OTC).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Oren LED Perioral Light Therapy System (Model: OR-01). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific acceptance criteria for a new clinical claim. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria related to clinical performance (e.g., reduction in fine lines and wrinkles).

Instead, the document focuses on demonstrating that the new device is as safe and effective as a previously cleared predicate device (reVive Perioral LED Light Therapy System, K172662) by comparing various design, performance, and safety parameters. The "acceptance criteria" in this context refer to demonstrating equivalence to the predicate and compliance with relevant safety and performance standards.

Here's an analysis based on the provided text, addressing your points where possible, and noting where the information is absent due to the nature of a 510(k) submission for substantial equivalence:

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

The "acceptance criteria" for a 510(k) in this context are primarily the demonstration of substantial equivalence to the predicate device and compliance with recognized safety and performance standards. The table provided is a comparison between the subject device and the predicate device, showing their similarities and differences.

Here's a re-imagined table focusing on the comparison elements as "criteria" for substantial equivalence and the reported performance of the subject device (Oren LED Perioral Light Therapy System) against these. The "Verdict" column essentially represents whether the criterion for equivalence was met.

Acceptance Criterion (Comparison Element)	Predicate Device Specification (Target)	Oren LED Perioral Light Therapy System (Reported Performance)	Verdict (Met/Not Met for Equivalence)
Classification Name	Light Based Over-The-Counter Wrinkle Reduction device	Light Based Over The Counter Wrinkle Reduction	Met (Same)
Product Code	OHS, ILY	OHS	Met (Functionally Same for primary prod code)
Intended Use / Indications for Use	Treatment of fine lines and wrinkles, and increase in circulation within the perioral region (OTC)	Treatment of fine lines and wrinkles, and increase in circulation within the perioral region (OTC)	Met (Same)
Type of use	Over-The-Counter Use	Over-The-Counter Use	Met (Same)
Treatment Distance	Applied directly to the skin	Applied directly to the skin	Met (Same)
Treatment Sites	Perioral region	Perioral region	Met (Same)
Change in energy (the addition of battery)	Yes	Yes	Met (Same)
Power Supply	3.7V lithium battery	3.7V lithium battery	Met (Same)
Time Range	3 minutes per treatment	3 minutes per treatment	Met (Same)
Wavelengths	605nm, 630nm, 660nm, 880nm	605nm, 630nm, 660nm, 880nm	Met (Same)
Energy Level	67.7 ± 10% mW/cm²	67.7 ± 10% mW/cm²	Met (Same)
Treatment Area	24 cm²	24 cm²	Met (Same)
Irradiance source	LED	LED	Met (Same)
Visible light LEDs	Yes	Yes	Met (Same)
Safety Standard Compliance	IEC 60601-1	ANSI AAMI ES60601-1	Met (Equivalent standards)
EMC Standard Compliance	IEC 60601-1-2	IEC 60601-1-2	Met (Same)
Biocompatibility Standards Compliance	ISO 10993-5, ISO 10993-10	ISO 10993-5, ISO 10993-10	Met (Same)
Design	Hand-held device	Portable equipment	Similar (Noted as not raising new safety/effectiveness questions due to compliance with home healthcare standards)
Components	LED module, USB charging cord, Storage bag	Main device, Mouthpiece, Charging base, Storage bag, Power cord, Adapter	Similar (Noted as not raising new safety/effectiveness questions due to same output parameters and safety compliance)
Number of LEDs	Total 56 LEDs (605nm: 14, 660nm: 14, 630nm: 14, 880nm: 14)	Total 38 LEDs (605nm: 10, 660nm: 10, 630nm: 12, 880nm: 6)	Similar (Noted as not raising new safety/effectiveness questions due to compliance with safety standards and same energy level)

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

The document does not describe a clinical study with a "test set" for efficacy in reducing fine lines and wrinkles. The "tests" mentioned (Section 8, "Test Summary") are laboratory bench testing to confirm compliance with electrical safety, EMC, usability, battery safety, and biocompatibility standards. These are not clinical studies. Therefore, there's no sample size or data provenance in the context of clinical 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. As noted above, there was no clinical "test set" for efficacy that would require expert ground truth establishment. The review is based on technical specifications and compliance with standards.

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

Not applicable. No clinical test set.

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 device is a light therapy system, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was done.

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

Not applicable. This is a light therapy device, not an algorithm.

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

For the 510(k) submission, the "ground truth" for the device's safety and performance is established by compliance with recognized standards (e.g., ANSI AAMI ES60601-1 for basic safety, IEC 60601-1-2 for EMC, ISO 10993 for biocompatibility) and demonstrating substantial equivalence to a predicate device that has previously been determined safe and effective for the indicated use. No clinical outcomes data for the subject device's efficacy are presented.

8. The sample size for the training set

Not applicable. This is a medical device for therapy, not an AI/machine learning model that requires a training set.

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

Not applicable. No training set for an AI model.

In summary:

This document is a 510(k) notification for a Class II medical device (Oren LED Perioral Light Therapy System). The core purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device already legally marketed. It does this by comparing the new device's intended use, technological characteristics, and performance (primarily safety and technical compliance) to the predicate.

The "study" described is a series of laboratory bench tests to ensure the device meets safety (electrical, EMC, battery), usability, and biocompatibility standards. It does not present a clinical study demonstrating the device's efficacy in treating fine lines and wrinkles, nor does it establish specific clinical acceptance criteria for such efficacy. The assumption is that because it is substantially equivalent to a cleared predicate device with the same intended use and energy parameters, it will achieve similar clinical outcomes.

Summary

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December 22, 2021

Shenzhen Kaiyan Medical Co Ltd Alain Dijkstra CEO 40A Fuxin Road, Fuyong Subdistrict, BaoAn District Shenzhen, Guangdong 518000 China

Re: K213024

Trade/Device Name: Oren LED Perioral Light Therapy System 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: October 18, 2021 Received: October 21, 2021

Dear Alain Dijkstra:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality 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) K213024

Device Name

Oren LED Perioral Light Therapy System (Model: OR-01)

Indications for Use (Describe)

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)

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510(k) Summary of K213024

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Date of the summary prepared: December 22, 2021

2. Submitter's Information

Company: SHENZHEN KAIYAN MEDICAL CO LTD Establishment Registration Number: 3011644607 Address:40a Fuxin Road Fuyong Subdistrict Baoan District Shenzhen Guangdong, CHINA Phone: 0755-82129361 Fax No: 0755-25024651 Contact Person (including title): Alain Dijkstra (CEO) Email: alaindijkstra@kaiyanmedical.com

Application Correspondent:

Contact Person: Mr. Alain Dijkstra Company: SHENZHEN KAIYAN MEDICAL CO LTD. Address: 40A Fuxin Road Fuyong Subdistrict BaoAn District Shenzhen, Guangdong, China Tel: +86 755 82129361 Email: regulation@kaiyanmedical.com

3. Subject Device Information

Type of 510(k): Traditional Classification Name: Light Based Over The Counter Wrinkle Reduction Trade Name: Oren LED Perioral Light Therapy System Model Name: OR-01 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 878.4810 Regulation Class: II

Predicate Device Information 4.

Sponsor: LED Technologies, Inc. Trade Name: reVive Perioral LED Light Therapy System Classification Name: Light Based Over-The-Counter Wrinkle Reduction device

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510(K) Number: K172662 Review Panel: General & Plastic Surgery Product Code: OHS, ILY Regulation Number: 878.4810 Regulation Class: II

5. Device Description

The Oren LED Perioral Light Therapy System is applied directly to the skin to ensure consistent administration of light during each treatment. The device is sold as Over the Counter (OTC).

Intended Use / Indications for Use 6.

7. Comparison to predicate device and conclusion

Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Verdict
Company	SHENZHEN KAIYAN MEDICAL COLTD	LED Technologies, Inc.	--
Trade Name	Oren LED Perioral Light TherapySystem	reVive Perioral LED Light TherapySystem	--
ClassificationName	Light Based Over The CounterWrinkle Reduction	Light Based Over-The-CounterWrinkle Reduction device	Same
510(k) Number	K213024	K172662	--
Product Code	OHS	OHS, ILY	Same
Intended Use /Indications for Use	The Oren LED Perioral Light TherapySystem (Model: OR-01) is an Over-the-Counter (OTC) device intendedfor the treatment fine lines andwrinkles, and increase in circulationwithin the perioral region.	The reVive® Perioral LED LightTherapy system is an Over-the-Counter (OTC) device intendedfor the treatment fine lines andwrinkles, and increase incirculation within the perioralregion.	Same

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Elements ofComparison	Subject Device	Predicate Device	Verdict
Design	Portable equipment	Hand-held device	SimilarNote 1
Components	- Main device- Mouthpiece- Charging base- Storage bag- Power cord- Adapter	- LED module- USB charging cord- Storage bag	SimilarNote 3
Type of use	Over-The-Counter Use	Over-The-Counter Use	Same
TreatmentDistance	Applied directly to the skin	Applied directly to the skin	Same
Treatment Sites	Perioral region	Perioral region	Same
Change in energy(the addition ofbattery)	Yes	Yes	Same
Power Supply	3.7V lithium battery	3.7V lithium battery	Same
Time Range	3 minutes per treatment	3 minutes per treatment	Same
Wavelengths	605nm, 630nm, 660nm, 880nm	605nm, 630nm, 660nm, 880nm	Same
Number of LEDs	Total 38 LEDs605nm: 10660nm: 10630nm: 12880nm: 6	Total 56 LEDs605nm: 14660nm: 14630nm: 14880nm: 14	SimilarNote 2
Energy Level	$67.7\pm10% \text{mW/cm}^2$	$67.7\pm10% \text{mW/cm}^2$	Same
Treatment Area	24 cm²	24 cm²	Same
Irradiance source	LED	LED	Same
Visible light LEDs	Yes	Yes	Same
Safety	ANSI AAMI ES60601-1	IEC 60601-1	Same
EMC	IEC 60601-1-2	IEC 60601-1-2	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same
Type/Class	OTC	OTC	Same

Comparison in Detail(s):

Note 1:

Although the "Design" of subject device is a little different from the predicate device, they are all compliance with requirements of ANSI AAMI ES/ IEC 60601-1-11. So, the differences between the subject device and predicate device will not raise any safety or effectiveness issue.

Note 2:

Although the "Number of LEDs" of subject device is a little different from the predicate device, they are all compliance with safety standards' requirements and they also have the same value in energy level. So, the differences between the subject device and predicate device will not raise any safety or effectiveness issue.

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Note 3:

Although the "Components" of the subject device are a little different from the predicate device, they are both have the same output wavelengths, energy level, treatment area, and others Treatment parameters, etc. And both are all in compliance with safety standards' requirements. So, the differences between the subject device ad predicate device will not raise any safety or effectiveness issues.

Test Summary 8.

The Oren LED Perioral Light Therapy System (Model: OR-01) has been evaluated the safety and performance by lab bench testing as following:

� ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
◆ IEC 60601-1-11 (Edition2.0):2015-01, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
◆ IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
� IEC 60601-2-57 Edition 1.0 2011-01 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
◆ IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
◆ IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
� ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
◆ ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

9. Final Conclusion:

The subject device is a safe, as effective, and perform as well or better than the legally marketed predicated device K172662.

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.