(168 days)
Not Found
No
The document describes a simple LED phototherapy device with a controller and flexible mask. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The software is described as "basic level concern."
Yes.
The device is indicated to treat medical conditions such as mild to moderate acne vulgaris and wrinkles, which constitutes a therapeutic use.
No
The device is described as a phototherapy device intended to treat dermatological conditions like acne and wrinkles. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is a "home wearable light-emitting diode phototherapy device" consisting of a "flexible silicone mask that contains LEDs and a controller." This indicates the device is a physical hardware product, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating dermatological conditions like acne and wrinkles. This involves applying light therapy directly to the skin, which is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a wearable LED mask that emits light for treatment. This aligns with a therapeutic device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the device's purpose is to treat conditions by applying light, which falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For MK-90C:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles.
For MK-90M:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90M) is an over the counter device intended for the use in the treatment of full face wrinkles.
For MK66RB-F:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK66RB-F) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris.
For MK-90N:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90N) is an over the counter device, is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The CurentBody™LED 4 in 1 Zone Facial Mapping Mask is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of mild to moderate acne vulgaris of the face. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface, Both surfaces are constructed of silicone The CurentBody™LED 4 in 1 Zone Facial Mapping Mask has 4 models, MK-90C, MK-90M, MK66RB-F and MK-90N.The controller contains a rechargeable lithium battery. The user charges the controller by connecting the charging cable with an adapter (AC100-240V, 50Hz/60Hz 5V 2A).The LED Light Therapy Mask cannot be operated while charging.
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 (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 and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC60601-1:2005+AMD1: 2012+AMD2: 2020, IEC 60601-1-2:2014+AMD1:2020, IEC TR 60601-4-2:2016, IEC 60601-1-11:2015+AMD1:2020, IEC 60601-2-57:2023, IEC 62471: 2006.
Biocompatibility tests were conducted and complied with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Skin Irritation), showing no cytotoxicity, no skin sensitization, and no irritation.
Light output test validated that the output of light from the same as stated in the specifications.
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." The software for this device was considered as basic level concern.
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 14, 2025
Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra CEO Building#3 and Building#5, 40th of Fuxin Street Huaide Community Fuyong Town Shenzhen, Guangdong 518103 China
Re: K242593
Trade/Device Name: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) 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 17, 2025 Received: January 17, 2025
Dear Alain Dijkstra:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
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,
Digitally signed by TANISHA TANISHA L. HITHE -S L.HITHE -○ Date: 2025.02.14
14:11:56 -05 16:11:56 -05'00'
Tanisha Hithe 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
3
Indications for Use
Submission Number (if known)
Device Name
CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90M, MK66RB-F, MK-90N)
Indications for Use (Describe)
For MK-90C:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles.
For MK-90M:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90M) is an over the counter device intended for the use in the treatment of full face wrinkles.
For MK66RB-F:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK66RB-F) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris.
For MK-90N:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90N) is an over the counter device, is generally indicated to treat dermatological conditions and specifically indicated for 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)
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4
510(k) Summary of K242593
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92
1.Submitter's Information
Sponsor Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Establishment Registration Number: 3011644607 Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: registrar01@kaiyanmedical.com
Application Correspondent
Contact Person (including title): Alain Dijkstra (Manager) Company: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Shenzhen, Guangdong 518103, China Shenzhen Guangdong 518103 China Tel: +86-135-10378748 Fax: +86-755-25024651 Email: registrar01@kaiyanmedical.com
Distributor:
Company: CurrentBody.Com Ltd Address: Q17, Crossley Road, Stockport, Greater Manchester, SK4 5BB United Kingdom
2.Subiect Device Information: Device Name:
Device Trade Name: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) Common Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Classification Name: Light Based Over The Counter Wrinkle Reduction Regulation Number: 21 CFR 878.4810 Product Code(s): OHS, OLP
Device Description Summary
The CurentBody™LED 4 in 1 Zone Facial Mapping Mask is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of mild to moderate acne vulgaris of the face. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface, Both surfaces are constructed of silicone The CurentBody™LED 4 in 1 Zone Facial Mapping Mask has 4 models, MK-90C, MK-90M, MK66RB-F and MK-90N.The controller contains a rechargeable lithium battery. The user charges the controller by connecting the charging cable with an adapter (AC100-240V, 50Hz/60Hz 5V 2A).The LED Light Therapy Mask cannot be operated while charging.
Intended Use/ Indications for Use:
5
For MK-90C:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: Mk-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles
For MK-90M:
The CurrentBody™ LED 4in 1 Zone Facial Mapping Mask(Models: MK-90M is an over the counter device intended for the use in the treatment of full face wrinkles.
- For MK66RB-F:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK66RB-F) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris.
For MK-90N:
The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask(Models: MK-90N) is an over the counter device, is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles.
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K214103 | Shani Darden LED light therapy mask | OLP, OHS |
| K240089 | Face Patches (MT-12MA, MT-12MC) | OHS, OLP, GEX |
3.Legally Marketed Predicate Devices:
4.General Comparison:
| Item | Subject Device
CurrentBody™ LED 4 in 1
Zone Facial Mapping
Mask(K242593) | Predicate Device 1
Shani Darden LED light
therapy
(K214103) | Predicate Device 2
Face Patches
(MT-12MA,
MT-12MC) (K240089) | Remark |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | OHS, OLP | OLP, OHS | OHS, OLP, GEX | Same |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| FDA Device
Classification | Class II | Class II | Class II | Same |
| Use | Over The Counter | Over The Counter | Over The Counter | Same |
| Item | Subject Device
CurrentBody™ LED 4 in 1
Zone Facial Mapping
Mask(K242593) | Predicate Device 1
Shani Darden LED light
therapy mask
(K214103) | Predicate Device 2
Face Patches
(MT-12MA,
MT-12MC) (K240089) | Remark |
| Indications
for
Use | For MK-90C:
The CurrentBody™ LED 4
in 1 Zone Facial Mapping
Mask (Models: MK-90C) is
an over the counter device,
specifically indicated to treat
mild to moderate acne
vulgaris of the face and
use in the treatment of
full-face wrinkles.
For MK-90M:
The CurrentBody™ LED 4
in 1 Zone Facial Mapping
Mask (Models: MK-90M) is
an over the counter device
intended for the use in the
treatment of full face
wrinkles.
For MK66RB-F:
The CurrentBody™ LED 4
in 1 Zone Facial Mapping
Mask (Models: MK66RB-F)
is an over the counter
device, specifically indicated
to treat mild to moderate
acne vulgaris.
For MK-90N:
The CurrentBody™ LED 4
in 1 Zone Facial Mapping
Mask (Models: MK-90N) is
an over the counter device,
is generally indicated to
treat dermatological
conditions and specifically
indicated for treatment of
periorbital wrinkles. | The Shani Darden LED
light therapy mask is an
over-the-counter device
intended to emit energy
in the red and blue
region of the light
spectrum, specifically
indicated to treat mild to
moderate acne vulgaris
of the face.
The Shani Darden LED
light therapy mask is an
over-the-counter device
intended to emit energy
in the red and Near
Infra-red spectrum and is
intended for the use in
the treatment of full-face
wrinkles. | Face Patches (Model:
MT-12MA) is an
Over-the-Counter
(OTC) device
intended for treatment
of mild to moderate
inflammatory acne.
Face Patches (Model:
MT-12MC) is an
Over-the-Counter
(OTC) device
intended for treatment
of mild to moderate
inflammatory acne
and full-face
wrinkles (including
periorbital wrinkles). | Similar
Note 1 |
| Intended location
of use | Face | Face | Face | Same |
| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| | CurrentBody™ LED 4 in 1
Zone Facial Mapping
Mask(K242593) | Shani Darden LED light
therapy mask (K214103) | Face Patches
(MT-12MA, MT-12MC)
(K240089) | |
| Energy
Type | Light emitting diodes | Light emitting diodes | Light emitting diodes | Same |
| Wavelen
gths | MK-90C
Mode 1: Red + Infrared
(633nm+830nm)
Mode 2: Blue + Red
(415nm+633nm)
Mode 3: Yellow + Infrared
(590nm+830nm)
MK-90M
Mode: Red + Infrared
(633nm+830nm)
MK66RB-F
Mode: Red + Blue (633nm
+415nm)
MK-90N
Mode: Yellow + Infrared
(590nm+830nm) | Blue: 415nm +/- 10nm
Red: 630nm +/- 10nm
NIR 830nm +/-10nm | MT-12MA: 415 ± 10nm
and 630 ± 10nm;
MT-12MC has 3 modes:
Mode 1: 630 ± 10nm and
415 ± 10nm,
Mode 2: 630 ± 10nm and
830nm ± 10nm,
Mode 3: 590nm ± 10nm | Similar
Note 2 |
| Power
Density | 415nm: 25±5mW/cm²;
633nm: 20±5mW/cm²;
590nm: 15±5mW/cm²;
830nm: 10±5mW/cm² | Blue: 28 mW/cm²
Red: 16 mW/cm²
and
Red: 18 mW/cm²
NIR: 11 mW/cm² | For MT-12MA:
630nm: 5 mW/cm²
415nm: 25 mW/cm²
630+415nm: 30 mW/cm²
For MT-12MC:
630nm (type 1): 5
mW/cm²
415nm: 25 mW/cm²
Mode 1 - total: 30
mW/cm²
830nm: 15 mW/cm2
630nm (type 2): 20
mW/cm²
Mode 2 - total: 35
mW/cm²
Mode 3 - 590nm: 35
mW/cm² | Different
Note 3 |
| LED
distribution | Uniform distribution | Uniform distribution | Uniform distribution | Same |
| Treatmen
t Time | 10 minutes | 10 minutes | For
MT-12MA(630+415nm):
3 minutes per treatment
For MT-12MCN(mode 1 -
630+415nm):
3 minutes per treatment
For MT-12MC (mode 2 -
630+830nm):
9 minutes per treatment
For MT-12MC (mode 3 -
590nm): | Same |
| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| Treatment protocol | CurrentBody™ LED 4 in 1
Zone Facial Mapping
Mask(K242593) | Shani Darden LED light
therapy mask (K214103) | Face Patches
(MT-12MA, MT-12MC)
(K240089) | Same |
| Software
Controlled | Device uses a timer and
software to control treatment
duration | Device uses a timer and
software to control treatment
duration | User interface software
allows the operator to
access and control all
device functions. | Same |
| Power
supply | MK-90C and MK-90N:
3.7Vdc, 5200mAh , 19.24Wh
Lithium battery
MK66RB-F and MK-90M:
3.7Vdc, 2600mAh , 9.62Wh
Lithium battery | 100-240V | Controller: 3.6V, 65mAh
lithium battery, 0.234Wh | Different
Note 4 |
| Power
input/output | Adapter Input:
100-240Vac,50-60Hz
Output: DC 5V,2A | Electrical Input to power
adaptor: 100v-240v.
50/60Hz. Rated at 0.7A.
Electrical Output from power
adaptor: 12V, 1A | NA | Same |
| | Wrinkles: 5 x weekly, 6
weeks
Acne: 4 x weekly, 6 weeks | Wrinkles: 5 x weekly, 6
weeks
Acne: 4 x weekly, 6 weeks | | |
6
7
Performance Comparison:
8
Safety Comparison:
| Item | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| CurrentBody ™ LED 4 in | ||||
| 1 Zone Facial Mapping | ||||
| Mask (K242593) | Shani Darden LED light | |||
| therapy mask | ||||
| (K214103) | Face Patches (MT-12MA, | |||
| MT-12MC) (K240089) | ||||
| Biocompatibility | ||||
| Cytotoxicit | ||||
| y Irritation | No Cytotoxicity Irritation | No Cytotoxicity Irritation | No Cytotoxicity Irritation | |
| Skin | ||||
| sensitizatio | ||||
| n | No evidence of skin | |||
| sensitization | No evidence of skin | |||
| sensitization | No evidence of skin | |||
| sensitization | Same | |||
| Irritation | No irritation | NA | No irritation | |
| EMC, Electrical Safety | ||||
| Electrical | ||||
| safety | Comply with IEC 60601-1 | Comply with IEC | ||
| 60601-1 | Comply with IEC 60601-1 | Same | ||
| EMC | Comply with IEC | |||
| 60601-1-2 | Comply with IEC | |||
| 60601-1-2 | Comply with IEC 60601-1-2 | Same | ||
| Home Use | Comply with IEC 60601-11 | Comply with IEC | ||
| 60601-11 | The proposed device is | |||
| Prescription Use and | ||||
| operated by professional | ||||
| personnel, so it does not | ||||
| need to be tested by IEC | ||||
| 60601-1-11 | Same |
9
| Particular
Requireme
nts | Comply with IEC
60601-2-57 | Comply with IEC
60601-2-57 | Comply with IEC
60601-2-57 | Same |
|--------------------------------|-------------------------------|-------------------------------|-------------------------------|------|
| Photobiolo
gical safety | Comply with IEC 62471 | Comply with IEC 62471 | Comply with IEC 62471 | Same |
Difference Analysis
Note 1: Although the "Indications for Use / Intended use" is a little different from the predicate devices, the acne treat function of the model MK-90C(mode 2) and MK66RB-F of subject device is consistent with predicate device 2 (Model: MT-12MA, K240089), the wrinkle removal function of the model MK-90C (mode 1,3), MK-90M and MK-90N of subject device is consistent with predicate device 1 (K214103) and predicate device 2 (Model: MT-12MC, K240089). So, this difference will not affect the safety and effectiveness of the subject device.
Note 2: The light wavelength is very similar but not identical. The proposed device emits blue light, red light, yellow light and IR light.
The variance range of each wavelength of the predicate devices is ±10nm, which can cover the wavelength of the proposed device. This represents a minor difference and not one to affect equivalence. The device has passed testing according to IEC 60601-2-57. Therefore, there is no effect on safety, effectiveness, or intended use of the proposed device.
The wavelengths of the subject device can be covered by the predicate devices. The MK-90C Mode 1 and MK-90M are both the combination of 633nm and 830nm. They are consistent with the model MT-12MC, mode 2 of the predicate device 2 (K240089, 630 ± 10nm and 830nm ± 10nm).
The wavelengths of MK-90C Mode 2 and MK66RB-F are both the combination of 633nm and 415nm, which are consistent with the model MT-12MA of predicate device 2 (K240089, 415 ± 10nm and 630 ± 10nm)
The wavelengths of MK-90C Mode 3 and MK-90N are both the combination of 590nm and 830nm, the yellow light can be consistent with the model MT-12MC, mode 3 of predicate device 3 (K240089).
So, the treatment wavelength of the subject device is acceptable.
Note 3: The proposed device has similar effective irradiance with the primary predicate device (K240089) in Red, Blue, Infrared, Yellow light source and also similar in combination of Red and Infrared type and combination of Blue and Red type. For the combination of Yellow and infrared type, the proposed device is different with predicate device (K240089).
From the comparison above, the power density of the combination of Yellow and infrared type is 15+10=25mW/cm², while mode 3 of Model MT-12MC of predicate device (K240089) is 35 mW/cm², we can see the proposed devices' effective irradiance is less than secondary predicate's, so it means the proposed device will not raise safety concerns in this particular difference.
Note 4: The proposed device and predicted devices are all powered by rechargeable Lithium battery. The battery in the proposed device supports a longer battery life as well as fast charging. This does not affect the safety, effectiveness, or indications for use of the proposed device.
Comparison conclusion
The proposed device and predicate devices have the same product code, regulation number, indications for use. There are a little differences in wavelength, power density and power input / output. But these differences will not result in differences on safety and performance between
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purposed device and the predicated device.
5.Test Summary
5.1Non-Clinical Test
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:
IEC60601-1:2005+AMD1: 2012+AMD2: 2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2014+AMD1:2020, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility-Requirements and tests.
IEC TR 60601-4-2:2016, Medical electrical equipment- Part 4-2: Guidance and interpretation -Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems.
IEC 60601-1-11:2015+AMD1:2020, 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 60601-2-57:2023,Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
IEC 62471: 2006 Photobiological safety of lamps and lamp system.
5.2Biocompatibility Test:
The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization), ISO 10993-23 (Skin Irritation).
5.3 Light output
The Light output test validated that the output of light from the same as stated in the specifications.
5.4 Software verification and validation
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." The software for this device was considered as basic level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
5.5 Clinical Test
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively..
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6. Date of the summary prepared: February 12, 2025
7. Final Conclusion
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K214103 and K240089.