(252 days)
Not Found
No
The device description focuses on the physical characteristics of the LED mask and its light emission properties. There is no mention of AI, ML, image processing, or any data-driven decision-making within the device's operation. The performance studies are related to usability and safety standards, not algorithmic performance.
Yes
The device is intended for the treatment of periorbital wrinkles and mild to moderate inflammatory acne, which are medical conditions, thus making it a therapeutic device.
No
The device is intended for the treatment of periorbital wrinkles and mild to moderate inflammatory acne, not for diagnosis.
No
The device description clearly states it is a "facemask-shaped device" with "150 LEDs" and is "powered via a plug-in power adapter," indicating it is a physical hardware device that emits light for therapeutic purposes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a facemask that applies light directly to the skin surface for the treatment of periorbital wrinkles and acne. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is for treatment, not for diagnosis or analysis of samples.
Therefore, this device falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
The device is indicated for adults only.
Product codes
OLP, OHS
Device Description
The LED THERAPY DEVICE is a facemask-shaped device, which directly applies light onto the face skin surface and makes use of specific light spectral characteristics.
The proposed device has total of 150 LEDs and operates in two modes. One mode emits blue light with wavelengths centered at 415nm ±5nm, and the other mode emits red light with wavelengths centered at 630nm ±5nm.
The red light is intended for the treatment of wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne.
The blue light mode has ten level energy output settings, 5mw/cm2-50mw/cm2. The red light mode has ten level energy output settings, 8mw/cm2-80mw/cm2.
The user can change the treatment mode according to their own needs. The LED THERAPY DEVICE is powered via a plug-in power adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face skin surface (implied by "facemask-shaped device" and "periorbital wrinkles" and "acne")
Indicated Patient Age Range
adults only
Intended User / Care Setting
Over-The-Counter 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Usability Study Summary
Study Type: Self-Selection, Labeling Comprehension, and Usability Study
Sample Size: 45 end-users (15 participants with mild inflammatory acne, 15 participants with moderate inflammatory acne, and 15 participants with periorbital wrinkles).
Key Results:
Results of Usability Study Questionnaire:
- Overall subject score of 100% in understanding of the device.
- 100% of each question relating to Risks, Warnings, Cautions, Precautions and a variety of other important data from the Instruction Manual, being correctly answered.
- Goal of question score ≥95% and participant overall score ≥95% was achieved.
Results of Operation demonstration of the device:
- 100% of the participants were able to: Correctly demonstrate how to install the device, perform the Light Sensitivity Test, operate the device, and clean & disinfect the device.
- Overall subject score of 100% was achieved.
Conclusion: All participants who represented the intended user population of the LED THERAPY DEVICE, understood how to decide whether or not they should use the device, understood the instruction for use, and could operate the device successfully.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
Beijing ADSS Development Co., Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 China
Re: K192295
Trade/Device Name: LED Therapy 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: OLP, OHS Dated: March 6, 2020 Received: March 9, 2020
Dear Ray 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. 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.
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
1
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 medical devices and radiation-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,
Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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) K192295
Device Name LED Therapy Device
Indications for Use (Describe)
The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
The device is indicated for adults only.
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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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: K192295
-
- Date of Preparation
04/30/2020
- Date of Preparation
-
Sponsor 2.
Beijing ADSS Development Co., Ltd.
1-2, Jinyuan Road 36, Daxing Economic Development Zone, Beijing, 102628, P.R. China Contact Person: Su CuiYing Position: Registration Manager Tel: +86-10-83625120 Fax: +86-10-83625121 Email: 2693743771@qq.com
- Submission Correspondent 3.
Mr. Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
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4. Identification of Proposed Device
Trade Name: LED THERAPY DEVICE Model(s): LED THERAPY DEVICE
Regulatory Information:
Classification Name: Light Based Over-The-Counter Powered Light Based Laser For Acne/Light Based over the Counter Wrinkle Reduction Classification: 2; Product Code: OLP/OHS; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Intended Use Statement:
The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. The device is indicated for adults only.
5. Device Description
The LED THERAPY DEVICE is a facemask-shaped device, which directly applies light onto the face skin surface and makes use of specific light spectral characteristics.
The proposed device has total of 150 LEDs and operates in two modes. One mode emits blue light with wavelengths centered at 415nm ±5nm, and the other mode emits red light with wavelengths centered at 630nm ±5nm.
The red light is intended for the treatment of wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne.
The blue light mode has ten level energy output settings, 5mw/cm2-50mw/cm2. The red light mode has ten level energy output settings, 8mw/cm2-80mw/cm2.
The user can change the treatment mode according to their own needs. The LED THERAPY DEVICE is powered via a plug-in power adapter.
5
Identification of Predicate Device 6.
Primary Predicate Device #1: 510(k) Number: K162098 Product Name: LED Phototherapy Device Manufacturer: Li-Tek Electronic Technology Corporation
Predicate Device #2: 510(k) Number: K172555 Product Name: Sapphire, Elevare Sapphire Manufacturer: Omm Imports, Inc. d/b/a Zero Gravity
7. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device conforms to the following standards:
| No. | Standard Title | Year | Recognition
Number |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------|
| 01 | ISO 10993-5, Biological evaluation of medical devices - Part 5:
Tests for In Vitro cytotoxicity | 2009 | 2-245 |
| 02 | ISO 10993-10, Biological evaluation of medical devices - Part
10: Tests for irritation and skin sensitization | 2010 | 2-174 |
| 03 | ANSI AAMI ES60601-1, Medical electrical equipment - Part 1:
General requirements for basic safety and essential
performance | 2005/(R)2012
and A1:2012 | 19-4 |
| 04 | IEC 60601-1-2, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests | 2014 | 19-8 |
| 05 | IEC 60601-1-11, 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 | 2015 | 19-14 |
| 06 | IEC 62471, Photobiological safety of lamps and lamp systems | 2006 | 12-249 |
| 07 | IEC 62366-1 Medical devices - Part 1: Application of usability
engineering to medical devices | 2015 | 5-114 |
- Usability Study Summary
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A Self-Selection, Labeling Comprehension, and Usability Study has been conducted for the LED THERAPY DEVICE.
The study was carried out from 2/17/2020 through 3/1/2020, at the AD Precision Health storefront and office, 2810 E Trinity Mills Rd #130, Carrollton TX 75006, America.
45 end-users enrolled for the study, which included 15 participants with mild inflammatory acne, 15 participants with moderate inflammatory acne, and 15 participants with periorbital wrinkles.
Results of Usability Study Questionnaire
The results from the questionnaire portion indicated an overall subject score of 100% in understanding of our device, with 100% of each question relating to Risks, Warnings, Cautions, Precautions and a variety of other important data from the Instruction Manual, being correctly answered. The results of this cohort found that an overall subject score of 100% was achieved, with 100% of each question correctly answered, thus reaching the goal of the question score ≥95% and the participant overall score ≥95%.
Results of Operation demonstration of the device
The results of this cohort found that 100% of the participants were able to:
-Correctly demonstrate how to install the device, perform the Light Sensitivity Test, operate the device, and clean & disinfect the device.
The results of this cohort found that an overall subject score of 100% was achieved. thus reaching the goal of Target Levels: Participant Overall score ≥95%. Conclusion:
According to the results of study, all participants who represented the intended user population of the LED THERAPY DEVICE, understood how to decide whether or not they should use the device, understood the instruction for use, and could operate the device successfully.
Clinical Test Conclusion 9.
No Clinical Test conducted.
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10. Substantially Equivalent (SE) Comparison
| Table 1 General Comparison | ||||
|---|---|---|---|---|
| ITEM | Proposed Device | Primary Predicate Device #1 | Predicate Device #2 | Remark |
| K162098 | K172555 | |||
| Product Code | OLP, OHS | OLP, OHS | OLP | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | Class 2 | Class 2 | Class 2 | SAME |
| Intended Use | The red light is intended for | |||
| the treatment of periorbital | ||||
| wrinkles and the blue light is | ||||
| intended for the treatment of | ||||
| the mild to moderate | ||||
| inflammatory acne. | ||||
| The device is indicated for | ||||
| adults only. | The red light is intended for | |||
| the treatment of periorbital | ||||
| wrinkles, and the blue light is | ||||
| intended for the treatment of | ||||
| the mild to moderate | ||||
| inflammatory acne. | The SAPPHIRE is an over | |||
| -the -counter hand held, | ||||
| battery operated, light | ||||
| therapy device that uses | ||||
| light emitting diodes | ||||
| (LEDs) that emit a specific | ||||
| wavelength of 415nm | ||||
| (Blue Light) that is | ||||
| intended for use in the | ||||
| treatment of mild to | ||||
| moderate inflammatory | ||||
| acne. | SAME | |||
| Prescription/ | ||||
| OTC | OTC | OTC | OTC | SAME |
Table 1 General Comparison
Table 2 Performance Comparison
| ITEM | Proposed Device | Primary Predicate Device #1
K162098 | Predicate Device #2
K172555 | Remark |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------|
| Power Source | 5.V DC 2.0 A
Powered by direct plug-in
adapter: Input 100-240V AC,
50/60 Hz, 0.5A Max., Output
5.0V DC 2.0A | 3.7V 1050mAh Li battery | Not Available | Difference
Analysis
as below
the table |
| Software/Firm
ware/Microproc
essor Control? | Yes | Yes | Yes | SAME |
| Power
(mW/cm²) | Red light: 80±10%
Blue light: 50±10% | Red light: 80±10%
Blue light: 65±10% | Blue light: 50 | SAME |
| Wavelength | Blue light: 415nm±5nm
Red light: 630nm±5nm | Blue light: 415nm±3nm
Red light: 630nm±3nm | Blue light: 415nm±5nm | SAME |
| Handheld | Yes | Yes | Yes | SAME |
| Treatment
Duration | 3-5 minutes each time, twice
a week | 3 minutes per target
area; 2 treatments per
week for 6 weeks | 4 minutes per area, twice
per week for 4 weeks
(total of 8 treatments) | SAME |
| Main Materials | PC+ABS | ABS plastic | Not Available | Difference
Analysis |
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| | | | as below
the table |
| -- | -- | -- | ----------------------- |
|---|
| ITEM | Proposed Device | Primary Predicate Device #1 | Predicate Device #2 | Remark |
|---|---|---|---|---|
| K162098 | K172555 | |||
| Electrical Safety | Comply with IEC 60601-1, | |||
| IEC 60601-1-11 | Comply with IEC 60601-1 | Comply with IEC 60601-1, | ||
| IEC 60601-1-11 | SAME | |||
| Photobiological | ||||
| Safety | Comply with IEC 62471 | Comply with IEC 62471 | Comply with IEC 62471 | SAME |
| EMC | Comply with IEC | |||
| 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC | ||
| 60601-1-2 | SAME | |||
| Biocompatibility | Comply with ISO 10993-1, | |||
| ISO 10993-5 and ISO | ||||
| 10993-10 | Comply with ISO 10993-1, | |||
| ISO 10993-5 and ISO | ||||
| 10993-10 | Comply with ISO 10993-1, | |||
| ISO 10993-5 and ISO | ||||
| 10993-10 | SAME | |||
| Label and | ||||
| Labeling | Conforms to FDA | |||
| Regulatory Requirements | Conforms to FDA Regulatory | |||
| Requirements | Conforms to FDA | |||
| Regulatory Requirements | SAME |
Table 3 Safety Comparison
Difference Analysis:
The subject device has indications for use, level of safety, and performance characteristics, that do not raise new types of questions regarding the safety and efficacy of the subject device.
For differences in the power sources, electrical safety testing according to IEC 60601-1 was conducted, and the test results demonstrated that the power source used in proposed device met the requirements of the standards.
For the device's user-contacting materials, biocompatibility testing according to ISO 10993 standard was conducted. The test results demonstrated that the materials used in proposed device met the requirements of the standard, and did not raise new safety or effectiveness concerns.
11. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate K162098.