(92 days)
Not Found
No
The summary describes a simple LED light therapy device with a single treatment mode and no mention of AI, ML, image processing, or data training/testing.
Yes
The device is described as "intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region," which are therapeutic claims. Furthermore, it explicitly states "intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use" under one of the performance studies (IEC 60601-2-57).
No
The device is described as an "Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation." It is a light-emitting device for therapeutic and cosmetic use, not for diagnosis.
No
The device description explicitly lists hardware components such as LEDs, a main device unit, charging base, power cord, adapter, and buttons. The performance studies also include testing against hardware safety and performance standards (e.g., IEC 60601 series).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of fine lines and wrinkles and increasing circulation within the perioral region. This is a therapeutic/cosmetic application, not a diagnostic one.
- Device Description: The device is a light-emitting diode (LED) system that applies light directly to the skin. This is a physical therapy/cosmetic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a person's health status, disease, or condition.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological specimens to aid in diagnosis, monitoring, or screening. This device operates in vivo (on the body) for therapeutic/cosmetic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
OHS
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Perioral region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter (OTC) device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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)
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.
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 (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).
Intended Use / Indications for Use 6.
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.
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 of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | SHENZHEN KAIYAN MEDICAL CO | ||
| LTD | LED Technologies, Inc. | -- | |
| Trade Name | Oren LED Perioral Light Therapy | ||
| System | reVive Perioral LED Light Therapy | ||
| System | -- | ||
| Classification | |||
| Name | Light Based Over The Counter | ||
| Wrinkle Reduction | Light Based Over-The-Counter | ||
| Wrinkle Reduction device | Same | ||
| 510(k) Number | K213024 | K172662 | -- |
| Product Code | OHS | OHS, ILY | Same |
| Intended Use / | |||
| Indications for Use | 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. | The reVive® Perioral LED Light | ||
| Therapy system is an Over-the- | |||
| Counter (OTC) device intended | |||
| for the treatment fine lines and | |||
| wrinkles, and increase in | |||
| circulation within the perioral | |||
| region. | Same |
5
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Design | Portable equipment | Hand-held device | Similar |
| Note 1 | |||
| Components | - Main device |
- Mouthpiece
- Charging base
- Storage bag
- Power cord
- Adapter | - LED module
- USB charging cord
- Storage bag | Similar
Note 3 |
| Type of use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Treatment
Distance | Applied directly to the skin | Applied directly to the skin | Same |
| Treatment Sites | Perioral region | Perioral region | Same |
| Change in energy
(the addition of
battery) | 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 LEDs
605nm: 10
660nm: 10
630nm: 12
880nm: 6 | Total 56 LEDs
605nm: 14
660nm: 14
630nm: 14
880nm: 14 | Similar
Note 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 10993-5
ISO 10993-10 | ISO 10993-5
ISO 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.