(85 days)
No
The description focuses on the hardware (LEDs, controller, AC adapter) and its function (emitting light of specific wavelengths for treatment). There is no mention of any software or algorithms that would process data, learn, or make decisions based on input, which are characteristic of AI/ML. The software mentioned is for control and safety, not for intelligent processing.
Yes
The device is intended for the "treatment of wrinkles and mild to moderate acne," which are medical conditions, and its function involves emitting light energy for this purpose.
No
The device is intended for the treatment of wrinkles and acne, not for diagnosing conditions.
No
The device description explicitly states it consists of a mask body unit, controller, and AC adapter, which are hardware components. It also mentions electrical safety and eye safety testing, which are relevant to hardware. While software verification and validation are mentioned, the device is clearly not solely software.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The LED Facial Mask uses light energy applied directly to the skin for therapeutic purposes (treating wrinkles and acne). It does not analyze any biological samples.
- Intended Use: The intended use clearly states treatment of wrinkles and acne, not diagnosis or analysis of biological samples.
Therefore, the LED Facial Mask falls under the category of a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Product codes
OHS, OLP
Device Description
The LED Facial Mask is an over-the-counter, facemask-shaped design light emitting diode (LED) device that emits light energy in the red, blue, and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The device consists of a mask body unit, controller, and AC adapter. The mask body unit contains light emitting diodes (LEDs) that emit visible red light (650nm+/-5nm), amber light (605nm+/-5nm), or blue light (465nm+/-5nm) to help reduce the appearance of wrinkles or mild to moderate acne. A controller is connected to the mask body unit to control the device, such as turn on/off the device, switch LED color output. An AC adapter is used to power the device. To use the device, user should place the mask body unit over the face and use the controller to operate. The device will automatically turn off after each treatment.
The LED Facial Mask includes MZ-01, NEWKEY-01, and SP-FM-01 models. Their intended use, performance, structure design, and operation are identical, with the difference being the product appearance, but these differences do not affect or change the intended use of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
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
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Safety
The materials of the patient-directly contacting components of the LED Facial Mask is ABS and PC plastic and performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:
- ISO 10993-5 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
- Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical Electrical Equipment -Part 1: 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 for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- Eye Safety
- IEC 62471 Photobiological safety of lamps and lamp systems
- Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
May 5, 2023
Shenzhen SUNGPO HI-TECH Electronic Co., Ltd % Rain Yip Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 ZhenYe International Center, No. 3101-90 Qianhai Road, Nanshan District Shenzhen, Guangdong 518000 China
Re: K230351
Trade/Device Name: LED Facial Mask 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 Dated: January 16, 2023 Received: February 9, 2023
Dear Rain Yip:
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.
Colin K. Chen -S
for
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)
Device Name
LED Facial Mask, Model(s): MZ-01, NEWKEY-01, SP-FM-01
Indications for Use (Describe)
LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
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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3
510(k) Summary K230351
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2023-01-16
I. Submitter
Shenzhen SUNGPO HI-TECH Electronic Co.,Ltd 806 Chuangke Building, No.72-6 Huanguan South Road, Xintian Community, Guanhu Street, Longhua District, Shenzhen city, China Post code: 518000 Tel .: +86 755 2333 7750
Ava Hu General Manager Tel: +86 183 1803 3721 Email: info@sungpo.com
II. Device
Name of Device: LED Facial Mask Model(s): MZ-01, NEWKEY-01, SP-FM-01 Classification name: Light Based Over The Counter Wrinkle and Acne Reduction Common Name: Light Based Over The Counter Wrinkle Reduction; Over-The-Counter Powered Light Based For Acne Regulatory Class: II Product Code: OHS, OLP Review Panel: General & Plastic Surgery Regulation Number: 21 CFR 878.4810
III. Predicate Device
| Predicate device | Predicate device | Reference device #1 | Reference device #2 |
|---|---|---|---|
| 510(k) number | K220168 | K203271 | K190443 |
| Sponsor | Shenzhen Kaiyan | ||
| Medical Co Ltd | Shenzhen Kaiyan | ||
| Medical CO LTD | Galactic Beauty, LLC | ||
| Device name | |||
| and model | Skin Care Beauty Mask | ||
| /MJ-06 | Aduro light therapy | ||
| Handheld/HD-03A | MMSphereTM | ||
| Product code | OHS, OLP | OHS, OLP | OHS, OLP |
| Approval date | May 17, 2022 | July 21, 2021 | June 24, 2019 |
IV. Device Description
The LED Facial Mask is an over-the-counter, facemask-shaped design light emitting diode (LED) device that emits light energy in the red, blue, and amber spectrum for the treatment of wrinkles
4
or mild to moderate inflammatory acne on the face. The device consists of a mask body unit, controller, and AC adapter. The mask body unit contains light emitting diodes (LEDs) that emit visible red light (650nm+/-5nm), amber light (605nm+/-5nm), or blue light (465nm+/-5nm) to help reduce the appearance of wrinkles or mild to moderate acne. A controller is connected to the mask body unit to control the device, such as turn on/off the device, switch LED color output. An AC adapter is used to power the device. To use the device, user should place the mask body unit over the face and use the controller to operate. The device will automatically turn off after each treatment.
The LED Facial Mask includes MZ-01, NEWKEY-01, and SP-FM-01 models. Their intended use, performance, structure design, and operation are identical, with the difference being the product appearance, but these differences do not affect or change the intended use of the device.
V. Indications for Use
LED Facial Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
VI. Comparison of Technological Characteristics With the Predicate Device
Compare with predicate devices, the subject device LED Facial Mask is very similar to or in the same design principle, intended use, functions, materials, and the applicable standards. The differences between subject device and the predicate devices do not raise new questions of safety or effectiveness.
| Comparison
Elements | Subject Device | Predicate device | Reference device
#1 | Reference device
#2 |
|-------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | LED Facial Mask/
MZ-01, NEWKEY-
01, SP-FM-01 | Skin Care Beauty
Mask /MJ-06 | Aduro light therapy
Handheld/HD-03A | MMSphere™ |
| 510(k) number | K230351 | K220168 | K203271 | K190443 |
| Product code | OHS, OLP | OHS, OLP | OHS, OLP | OHS, OLP |
| Classification
name | Light Based Over
The Counter Wrinkle
and Acne Reduction | Light Based Over
The Counter
Wrinkle Reduction
(OHS) Over-The-
Counter Powered
Light Based Laser
For Acne (OLP) | Light Based Over
The
Counter
Wrinkle and Acne
Reduction | Light Based Over
The Counter Acne
and
Wrinkle
Reduction |
| Indication for
device | LED Facial Mask is
an over the counter
device that is
to | The Skin Care
Beauty Mask
(Model: MJ 06) | The Aduro light
therapy Handheld
(Model: HD 03A) | MMSphere™
Light Therapy
Device emits
to |
| Comparison
Elements | Subject Device | Predicate device | Reference
device
#1 | Reference device
#2 |
| | acne. | indicated to treat
full face wrinkles
and/or mild to
moderate acne. | wrinkles, and the
blue light is
intended for the
treatment of the
mild to moderate
inflammatory acne. | specifically
indicated to treat
wrinkles and/or
mild to moderate
acne.
The MMSphere™
is designed to be
used for 20
minute treatments
three to seven
times per week. |
| Location for use | Face | Face | Face | Face |
| Treatment time | 10 minutes/day, 3
times per week | 5 or 10
minutes/day, 3
times per week | 3-5 minutes on
each treatment
area. For best
results 3-5 times
per week with 2
day rest. | 20mins/day,
120days |
| Environment
for use | OTC | OTC | OTC | OTC |
| Power supply | An external adapter
Input: AC 100-240V
50-60Hz 0.2A
Output: DC 12V
0.5A | Adapter:
Input: 100-
240Va.c., 50/60Hz,
0.5A
Output: 5.0Vd.c.,
2.0A | 2600mAh, 3.7V Li
battery | Not publicly
available |
| Irradiance
source | Light emitting diodes
(LEDs) | Light emitting
diodes (LEDs) | Light emitting
diodes (LEDs) | Light emitting
diodes (LEDs) |
| LED
Wavelengths | Blue: 465nm±5nm
Red: 625nm±5nm
Amber: 605nm±5nm | Blue: 465nm±10nm
Red: 640nm±10nm | Blue: 415nm±10nm
Red: 630nm±10nm
IR: 850nm | Amber: 605nm
Red: 625nm
Blue: 465nm |
| LED
Power
density | Blue: 1563mW/cm²75mW/cm² | Blue: 30mW/cm²
Red: 31
Red: 30mW/cm² | Blue:
2065mW/cm²80mW/cm² | Blue:
Red:
40
1.33mW/cm²
Red:
2.45mW/cm² |
| Material
of
device
and
construction | ABS and PC plastic | Not publicly
available | ABS plastic | Not publicly
available |
| Biocompatibility feature | Comply with
ISO10993-1,
ISO10993-5 and
ISO10993-10 | Comply with
ISO10993-1,
ISO10993-5 and
ISO10993-10 | Comply with
ISO10993-1,
ISO10993-5 and
ISO10993-10 | Comply with
ISO10993-5 and
ISO10993-10 |
| Comparison
Elements | Subject Device | Predicate device | Reference device
#1 | Reference device
#2 |
| Compliance
with voluntary
standards | IEC60601-1-2 | IEC60601-1-2 | | IEC60601-1-2 |
| | IEC60601-1 | IEC60601-1 | | IEC60601-1 |
| | IEC60601-1-11 | IEC60601-1-11 | Not publicly
available | IEC60601-1-11 |
| | IEC60601-2-57 | IEC60601-2-57 | | IEC60601-2-57 |
| | IEC62471 | IEC62471 | | IEC62471 |
5
6
VII.Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Safety
The materials of the patient-directly contacting components of the LED Facial Mask is ABS and PC plastic and performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:
-
ISO 10993-5 Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10 Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and Eye Safety
Electrical safety and Eye safety testing was performed to, and passed, the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1: 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 for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
3) Eve Safety
-
IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. Summary
7
Based on the above performance as documented in this application, the LED Facial Mask was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the LED Facial Mask is to be concluded substantial equivalent to its predicate device.