(90 days)
No
The device description and performance studies focus on the light therapy technology and safety standards, with no mention of AI or ML capabilities.
Yes
The device is described as treating wrinkles, acne, arthritis, and muscle spasms, and promoting relaxation and increased blood circulation, which are all therapeutic claims. Furthermore, it explicitly states compliance with IEC 60601-2-57, which covers "non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use."
No
Explanation: The device is described as a phototherapy device for treatment (e.g., wrinkles, acne, pain relief). There is no mention of it being used to identify or analyze a condition.
No
The device description explicitly lists hardware components: mask, controller, adapter, USB cable, and straps. The performance studies also include testing for electrical safety and biocompatibility, which are relevant to hardware. While software verification and validation were conducted, the device is clearly not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended uses listed are for the treatment of skin conditions (wrinkles, acne) and musculoskeletal issues (arthritis, muscle spasm, stiffness). These are all therapeutic applications performed directly on the patient's body.
- Device Description: The device is a wearable LED light therapy mask that applies light to the skin.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is clearly intended for direct therapeutic application to the patient, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
Red light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Mixed light: Treatment of mild to moderate inflammatory acne.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP, ILY
Device Description
LED light therapy mask is a home use wearable LED phototherapy device which can help solve various skin problems. LED light therapy mask is consisting of mask, controller, adapter, USB cable and straps.
There are 4 kinds of light which include Red light (wavelength 620mm), Blue light (wavelength 460nm), Infrared light (wavelength 850mm), Mixed light (wavelength 620mm and 850nm and 460nm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face and body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use / 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)
Non-clinical data:
Non-clinical tests have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- ANSI AAMI ES 60601-1, Medical electrical equipment Part 1: General A requirements for basic safety and essential performance
- A 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
-
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
- IEC 60601-2-57, Medical Electrical Equipment Part 2-57: Particular requirements A for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Biocompatibility Test:
The device has been tested for biocompatibility; it complies with the following standards.
-
ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Clinical data: Not applicable.
Summary:
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
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.
K200983, K221151, K162489, K212155
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.
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.
0
Image /page/0/Picture/0 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
February 23, 2023
Guangdong Newdermo Biotech Co.,Ltd Annie Cai Certificate Engineer Building C28. Huachuang Industrial Park, Jinshan Avenue Shiji Town, Panyu Guangzhou. 511450 China
Re: K223544
Trade/Device Name: LED light therapy mask (FM-01, FM-02, FM-03) 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, OLP, ILY Dated: November 24, 2022 Received: November 25, 2022
Dear Annie Cai:
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 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.
Jianting Wang -S
Jianting Wang 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
2
Indications for Use
510(k) Number (if known) K223544
Device Name LED light therapy mask (FM-01, FM-02, FM-03)
Indications for Use (Describe)
Red light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mixed light: Treatment of mild to moderate inflammatory acne.
Type of Use (Select one or both, as applicable)
| For activities identified in 37.44, Subpart D | |
|---|---|
| For Streamlined permitting under 37.44, Subpart C |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary K223544
4
510 (K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
1. Submitter:
| 510(k) owner's name: | Guangdong Newdermo Biotech Co.,Ltd |
|---|---|
| Address: | Building C28. Huachuang Industrial Park |
| Jinshan Avenue, Shiji Town, | |
| Panyu, Guangzhou, | |
| 511450 P.R. China | |
| Tel: | +86(020) 31105688 |
| Contact person: | Annie Cai |
| Email: | caidejiao@qq.com |
| Preparing date: | February 22, 2023 |
| 2. Device name and classification: | |
| Device Name: | LED light therapy mask |
| Model: | FM-01, FM-02, FM-03 |
| Classification Name/ | |
| Product code: | 21 CFR 878.4810 OHS |
| 21 CFR 878.4810 OLP | |
| 21 CFR 890.5500 ILY | |
| Regulatory Class: | Class II |
3.Premarket Notification Class III Certification and Summary
Not applicable, the subject device is Class II.
4. Predicate Device(s):
1) Predicate device1
| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|---|---|
| Device name: | LED FACIAL LIGHT THERAPY MASK, FLEXIBLE LED LIGHT |
| THERAPY | |
| 510(k) Number: | K200983 |
| Product Code: | OHS, OLP, ILY |
| 2) Predicate device2 | |
| Sponsor: | Hunan Guangye Biotechnology Co., Ltd. |
| Device name: | Beauty LED Mask |
5
Traditional 510(k) Submission of LED light therapy mask
| 510(k) Number: | K221151 |
|---|---|
| Product Code: | OHS, OLP |
| 3) Predicate device3 | |
| Sponsor: | Zhongshan Bisen Plastic Electronic Products Co.,Ltd. |
| Device name: | RED Light Device |
| 510(k) Number: | K162489 |
| Product Code: | OHS |
| 4) Predicate device4 | |
| Sponsor: | Theragun, Inc. |
| Device name: | TheraFace LED |
| 510(k) Number: | K212155 |
| Product Code: | OHS, OLP |
| 5) Reference device | |
| Sponsor: | Xuzhou Kernel Medical Equipment Co., Ltd. |
| Device name: | LED Light Therapy Device, KN-7000L |
| 510(k) Number: | K222751 |
| Product Code: | GEX |
5. Reason for Submission
New device, there were no prior submissions for the device.
6. Pre-Submission, IDE
Not applicable, there is no prior submission.
7. Device Description:
LED light therapy mask is a home use wearable LED phototherapy device which can help solve various skin problems. LED light therapy mask is consisting of mask, controller, adapter, USB cable and straps.
There are 4 kinds of light which include Red light (wavelength 620mm), Blue light (wavelength 460nm), Infrared light (wavelength 850mm), Mixed light (wavelength 620mm and 850nm and 460nm).
8. Intended Use:
Red light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
6
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Mixed light: Treatment of mild to moderate inflammatory acne.
| Item | Subject Device | Predicate
device1(K200983) | Predicate
Device2(K221151) | Comparison
Result |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Trade name | LED light therapy
mask | LED FACIAL
LIGHT
THERAPY
MASK,
FLEXIBLE LED
LIGHT
THERAPY | Beauty LED Mask | / |
| 510 (k) number | K223544 | K200983 | K221151 | / |
| Manufacturer | Guangdong
Newdermo Biotech
Co.,Ltd | NINGBO HESI
ELECTRIC CO.,
LTD | Hunan Guangye
Biotechnology Co.,
Ltd. | / |
| Regulation
number | 21 CFR 878.4810
21 CFR 890.5500 | 21 CFR 878.4810,
21 CFR 890.5500 | 21 CFR 878.4810 | Same |
| Regulation
Name | Light Based Over
The Counter
Wrinkle
Reduction(OHS),
Over-The-Counter
Powered Light
Based Laser For
Acne(OLP),
Infrared,
Therapeutic
Heating(ILY) | Light Based Over
The Counter
Wrinkle
Reduction(OHS),
Over-The-Counter
Powered Light
Based Laser For
Acne(OLP),
Lamp, Infrared,
Therapeutic
Heating(ILY) | Light Based Over
The Counter
Wrinkle
Reduction(OHS),
Over-The-Counter
Powered Light
Based Laser For
Acne(OLP) | Same |
| Product code | OHS, OLP, ILY | OHS, OLP, ILY | OHS, OLP | Same |
| Classification | II | II | II | Same |
| Indications for
use/ Intended
use | Red light:
Treatment of
full-face wrinkles.
Blue light:
Treatment of mild
to moderate
inflammatory acne. | The LED FACIAL
LIGHT
THERAPY
MASK (Model:
HK207) is
intended to:
The device | The device is
intended to use
LED light for the
treatment of
wrinkles and mild
to moderate acne. | Similar
Note2 |
9. Predicate Device Comparison
7
| Infrared light:
Provide topical
heating for the
purpose of
elevating tissue
temperature;
arthritis and muscle
spasm; relieving
stiffness; promoting
the relaxation of
muscle tissue; and
to temporarily
increase local blood
circulation.
Mixed light:
Treatment of mild
to moderate
inflammatory acne. | emitting energy in
the blue is
intended to reduce
the mild to
moderate
inflammatory acne
vulgaris.
- The device
emitting energy in
the red and
infrared spectrum
is intended for the
treatment of
full-face wrinkles.
The FLEXIBLE
LED LIGHT
THERAPY
(Model: HK209) is
intended to: - The device
emitting energy in
the blue is
intended to reduce
the mild to
moderate
inflammatory acne
vulgaris. - The device
emitting energy in
the red and
infrared spectrum
is intended for the
treatment of
full-face
wrinkles. - The device is
intended to deliver
heat in the IR
spectrum to
provide topical
heating for the
purpose of
elevating tissue | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
8
| | | the temporary
relief of minor
muscle and joint
pain, arthritis and
muscle spasm;
relieving stiffness;
promoting the
relaxation of
muscle tissue; and
to temporarily
increase local
blood circulation. | | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Location for use | Face and body | Entire Face and
body | Face | Same |
| OTC or
prescription | OTC | OTC | OTC | Same |
| Power supply | Input:
100-240 V~, 50/60
Hz, 0,25 A
Output: DC 5 V,
500 mA | Input: 100 –
240Vac,
2.0 A, 50/60Hz | Input: 100 -240 V
~ 50 /60 Hz
Output: 5V 1A | Similar
Note4 |
| Light source | LED | LED | LED | same |
| Wavelength | Red: 620nm
Blue: 460nm
Infrared: 850nm
Mixed: 620nm and
850nm and 460nm | 465nm,
640nm,
880nm | Red (637nm±5nm)
and
IR (854nm±5nm);
Blue (465±5nm) | Compare
with
predicate
device 4
Similar
Note 5 |
| LED Intensity | Red light: 2.03.04.0
mW/cm²
Blue light:2.0
mW/cm²
Infrared light:
2.04.0 mW/cm²12.0 mW/cm² | 6.5 mW/cm² | Red+IR:
Mixed light:
9.0
25.5mW/cm²
Blue: 1.36mW/cm² | Similar
Note6 |
| Treatment time | Manual Mode:
15minutes each
time,
Automatic Mode:
10minutes each
time.
3-4 treatment a
week, reduce to 1-2 | 3 times a week for
30
min. 4 weeks | 10min each time | Compare
with
predicate
device 3
Similar
Note7 |
| | treatment a week
once the results
shown. | | | |
| Dimensions
(mm) | FM-01:
207X277X43mm,
FM-02:
198X383X33.5mm,
FM-03:
237.5X108X8.1mm | Not public | LED Mask:
Approximately 183 mm x 238 mm x 98 mm
Controller: 100mm x 50 mm x 21.5 mm | / |
| Electrical safety | IEC 60601-1;
IEC 60601-1-2 | IEC 60601-1;
IEC 60601-1-2 | IEC 60601-1;
IEC 60601-1-2 | Same |
| Biocompatibility
feature | All body-contacting
materials are
complied with
ISO10993-5 and
ISO 10993-10 | All
body-contacting
materials are
complied with
ISO10993-5 and
ISO 10993-10 | All
body-contacting
materials are
complied with
ISO10993-5 and
ISO 10993-10 | Same |
9
| Item | Subject Device | Predicate
device3(K162489) | Predicate
Device4(K212155) | Comparison
Result |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Trade name | LED light therapy
mask | RED Light Device | TheraFace LED | / |
| 510 (k) number | K223544 | K162489 | K212155 | / |
| Manufacturer | Guangdong
Newdermo Biotech
Co.,Ltd | Zhongshan Bisen
Plastic Electronic
Products Co.,Ltd. | Theragun, Inc. | / |
| Regulation
number | 21 CFR 878.4810,
21 CFR 890.5500 | 21 CFR 878.4810 | 21 CFR 878.4810 | Similar
Note1 |
| Regulation
Name | Light Based Over
The Counter
Wrinkle
Reduction(OHS),
Over-The-Counter
Powered Light
Based Laser For
Acne(OLP),
Infrared,
Therapeutic
Heating(ILY) | Light Based Over
The Counter
Wrinkle
Reduction(OHS), | Light Based Over
The Counter
Wrinkle
Reduction(OHS), | Similar
Note1 |
| Product code | OHS, OLP, ILY | OHS | OHS, OLP | Similar
Note1 |
| Classification | II | II | II | Same |
| Indications for
use/ Intended
use | Red light: | 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. | 1) The red light is
intended to treat
periorbital
wrinkles.
2) The blue light is
intended to treat
mild to moderate
inflammatory acne.
3) The Red + IR
is intended to treat
periorbital
wrinkles. | Similar
Note2 |
| Red light:
Treatment of
full-face wrinkles
Blue light:
Treatment of mild
to moderate
inflammatory acne.
Infrared light:
Provide topical
heating for the
purpose of
elevating tissue
temperature;
arthritis and muscle
spasm; relieving
stiffness; promoting
the relaxation of
muscle tissue; and
to temporarily
increase local blood
circulation.
Mixed light:
Treatment of mild
to moderate
inflammatory acne. | | | | |
| Location for use | Face and body | / | Face | Similar
Note3 |
| OTC or
prescription | OTC | OTC | OTC | Same |
| Power supply | Input:
100-240 V~, 50/60
Hz, 0,25 A
Output: DC 5 V,
500 mA | Adaptor:100240V3.0 | 125 mW/cm² | Red light 73±5 | Compare
AC 50/60Hz
Lithium battery:
2x3.7V | Lithium
battery :2x3.7V | Similar
Note4 |
| Light source | LED | LED | LED | Same |
| Wavelength | Red: 620nm
Blue: 460nm
Infrared: 850nm
Mixed: 620nm and
850nm and 460nm | Red: 633 ±5nm
Infrared: 830 ±5nm | Red light:
633nm±10nm
Blue light:
415nm±10nm
Red+IR:
633±10nm /
830nm±10nm | Compare
with
predicate
device 4
Similar
Note 5 |
| LED Intensity | Red light: 2.0
with |
| | Blue light:2.04.04.0 mW/cm²
mW/cm²
Infrared light:
2.0
Mixed light:
9.0~12.0 mW/cm² | nm); 55 mW/cm²
(830nm) | Blue light 64±5
mW/cm²
Red+IR:
73±5/55±5
mW/cm² | predicate
device 3
Similar
Note6 |
| Treatment time | Manual Mode:
15minutes each
time,
Automatic Mode:
10minutes each
time.
3-4 treatment a
week, reduce to 1-2
treatment a week
once the results
shown. | 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). | Red light: 5 - 7
minutes per
treatment zone
Blue: 5-7 minutes
per treatment zone
Red+IR: 5-7
minutes per
treatment zone | Compare
with
predicate
device 3
Similar
Note7 |
| Dimensions
(mm) | FM-01:
207X277X43mm,
FM-02:
198X383X33.5mm,
FM-03:
237.5X108X8.1mm | / | / | / |
| Electrical safety | IEC 60601-1;
IEC 60601-1-2 | IEC 60601-1;
IEC 60601-1-2 | IEC 60601-1;
IEC 60601-1-2 | Same |
| Biocompatibility
feature | All body-contacting
materials are
complied with
ISO10993-5 and
ISO 10993-10 | All
body-contacting
materials are
complied with
ISO10993-5 and
ISO 10993-10 | All
body-contacting
materials are
complied with
ISO10993-5 and
ISO 10993-10 | Same |
Guangdong Newdermo Biotech Co.,Ltd
10
11
Comparison in Detail(s):
Note1
The Regulation number, Regulation Name, Product code of predicate1 are not identical to the subject device, all these device are process similar intended use and use very similar light wavelengths to get the intended purpose. This slight deference will not raise safety and effective issue.
Note2
The Indications for use/ Intended use of Red light, Blue light , Infrared light of the subject device is the same as that of primary device K200983. The Indications for use/ Intended use of mixed light of the subject device is the same as that of secondary device K221151.
12
Note3
The treatment location of the subject device is the same as the predicate device K200983 but identical the other predicate device. The difference in applicable location will not raise safety and effective issue.
Note4
The power supply of devices are very similar but not identical, the IEC60601-1test demonstrated the safety of the power adapter. The slight difference will not raise safety and effective issue. Note5
The light wavelength is very similar but not identical. The subject device emits blue light, red light and IR light. In the mixed light mode, the subject device emits blue light, IR light simultaneously, while the reference device K222751 can emit red, blue, IR light simultaneously and it has been demonstrated that emit three lights simultaneously is safe and effect. Besides, the subject device has passed IEC60601-2-57 test, the slight difference will not raise safety and effective issue.
Note6
The LED Intensity of these devices are different, and the LED intensity of the subject device is low and subject device has passed IEC60601-2-57 test, the slight difference will not raise safety and effective issue.
Note7
The treatment time of these devices are very similar but not identical, treatment is one of the factors to get the intended purpose. What's more, the subject device has IEC60601-1, IEC60601-2-57 test, the slight difference will not raise safety and effective issue.
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the product come into conclusion.
10. Performance Data:
Non-clinical data:
Non-clinical tests have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- ANSI AAMI ES 60601-1, Medical electrical equipment Part 1: General A requirements for basic safety and essential performance
- A 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
-
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
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- IEC 60601-2-57, Medical Electrical Equipment Part 2-57: Particular requirements A for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
Biocompatibility Test
The device has been tested for biocompatibility; it complies with the following standards.
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ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Clinical data: Not applicable.
Summary
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
11. Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that LED light therapy mask should perform as intended in the specified use conditions, and all the data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject device (LED light therapy mask) is Substantial Equivalent to the predicate devices K200983, K221151, K162489 and K212155.