(128 days)
No
The summary describes a simple LED light therapy device with no mention of AI/ML components, data processing, or algorithms.
Yes
The device is indicated for "the treatment of periorbital wrinkles," which is a therapeutic purpose.
No
The device is indicated for treatment (periorbital wrinkles), not for diagnosis.
No
The device description explicitly states it is a battery-operated device composed of a handpiece, base unit, and charging adapter, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The RED Light Device emits light energy to treat periorbital wrinkles. It does not analyze any biological samples.
- Intended Use: The intended use is for the treatment of a physical condition (wrinkles) through the application of light, not for diagnostic testing.
The description clearly indicates it's a therapeutic device for dermatological use.
N/A
Intended Use / Indications for Use
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.
Product codes
OHS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home-use
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 data was not included in this submission.
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.
0
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
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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: __
-
- Date of Preparation
08/23/2016
- Date of Preparation
-
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
4
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 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.
5
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.
6
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 for | |||
| Use | 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. | Perfectio LED infrared device is an | ||
| over the counter device indicated to | |||
| emit energy in the red and IR region | |||
| of the spectrum for use in | |||
| dermatology for the treatment of | |||
| periorbital wrinkles. | SE |
Table 1 General Comparison
7
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Handheld | Yes | Yes | SE |
| Contacting | |||
| Materials | ABS & Stainless Steel | ABS & Stainless Steel | SE |
| Measurement | |||
| wavelength | Red: 633 ±5nm | ||
| Infrared: 830 ±5nm | Red: 633 ±5nm | ||
| Infrared: 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/cm2 | ||
| 70 mW/cm2 (633 nm); 55 mW/cm2 (830 nm) | 125 mW/cm2 | ||
| 70 mW/cm2 (633 nm); 55 mW/cm2 (830 nm) | SE | ||
| Power Supply | Adaptor: 100~240V AC 50/60Hz | ||
| Lithium battery: 2x3.7V | Adaptor: 100~240V AC 50/60Hz | ||
| Lithium battery: 2x3.7V | SE | ||
| 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). | 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). | SE | ||
| Maintenance | |||
| Regime | Individuals with periorbital lines and | ||
| wrinkles | Individuals with periorbital lines and | ||
| wrinkles | SE |
Table 2 Performance Comparison
8
| 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.