(84 days)
No
The device description focuses on the use of LED light at specific wavelengths and a simple controller for basic functions (on/off, mode switching). There is no mention of AI, ML, image processing, or any data processing that would suggest intelligent algorithms are involved. The performance studies listed are standard safety and software validation tests, not studies related to AI/ML performance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to use LED light for the treatment of wrinkles and mild to moderate acne," which are therapeutic applications.
No
The device is described as an over-the-counter therapeutic device for treating wrinkles and acne, not for diagnosing conditions. Its function is to emit LED light, not to analyze patient data for diagnostic purposes.
No
The device description explicitly details hardware components (LEDs, mask form, controller, eye-shield) and the performance studies include electrical safety, EMC, eye safety, and biocompatibility testing, all of which are related 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 Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The LED Light Therapy Mask uses light to treat wrinkles and acne directly on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states treatment of wrinkles and acne, not diagnosis or detection of conditions through sample analysis.
The device is a therapeutic device that applies light energy to the skin for treatment purposes.
N/A
Intended Use / Indications for Use
LED Light Therapy 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 (comma separated list FDA assigned to the subject device)
OHS, OLP
Device Description
The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (620mm±10mm), blue (460±10nm) and infrared (850nm=10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller (Only for SKB-2318L,SKB-2318PRO, IN-FM002,SKB-2418) is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.
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 studies and tests performed:
- Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
- ANSI AAMI ES 60601-1, Medical electrical equipments for basic safety and essential performance A
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic salety and esential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11, Medical electrical equipments - 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
- A IEC 60601-2-57 Medical electrical equipments - Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
- IEC 62133-2, Secondary cells and batteries ontaining alkaline or other non-acid electrolytes Safety requirements for portable sealed secondary cells, A and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- Eye Safety
- A IEC 62471 Photobiological safety of lamps and lamp systems
- Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the was conducted 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", as recognized by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity A
- ISO 10993-10:2021, Biological evaluation of medical devices –Part 10: Tests for skin sensitization A
- A ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation
We have also conducted: - Software verification and validation test according to the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
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.
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, 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.
December 20, 2024
Shenzhen Siken 3D Technology Development Co., Ltd. % Huang Bing RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K243040
Trade/Device Name: LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) 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: September 26, 2024 Received: September 27, 2024
Dear Huang Bing:
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/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
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 (QS) 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 Rule"). 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-udi-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 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-regulatory
2
assistance/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 YAN FU -S
Date: 2024.12.20 15:18:49
YAN FU -S
-05'00'
for 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
510(k) Number (if known) K243040
Device Name
LED Light Therapy Mask/Model: SKB-1818P.SKB-1918P.SKB-1918P.SKB-1918PLUS,SKB-2318L,S KB-2318P,SKB-2318PRO,IN-FM002,SKB-2418
Indications for Use (Describe)
LED Light Therapy 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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4
K243040 - 510 (k) Summary
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | Shenzhen Siken 3D Technology Development Co., Ltd. |
|---|---|
| Address: | 4th Building, No.33 Left East Avenue, Songgang, Bao'an District, |
| Shenzhen, Guangdong, China | |
| Contact person: | Jing Quan Liu |
| Phone number: | +86-0755-27697523 |
| Fax number: | +86-0755-27697523 |
| Email: | 1550420556@qq.com |
| Date of summary prepared: | 2024-9-27 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/model: | LED Light Therapy Mask/Model:
SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,S
KB-2318P,SKB-2318PRO,IN-FM002,SKB-2418 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Light Based Over The Counter Wrinkle Reduction(OHS)
Over-The-Counter Powered Light Based Laser For Acne(OLP) |
| Regulation number: | 21 CRF 878.4810 |
| Product code: | OHS, OLP |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(4) Predicate and reference device
> Predicate device 1
| Sponsor | Hunan Guangye Biotechnology Co., Ltd. |
|---|---|
| Device Name and Model | Beauty LED Mask/ Mode: KFB265 |
| 510(k) Number | K221151 |
| Product Code | OHS, OLP, |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | Class II |
Predicate device 2 >
5
Shenzhen Siken 3D Technology Development Co., Ltd. 510(k)s – Section 8. 510 (k) Summary
| Sponsor | Shenzhen SUNGPO HI-TECH Electronic Co., Ltd |
|---|---|
| Device Name and Model | LED Facial Mask |
| 510(k) Number | K230351 |
| Product Code | OHS, OLP |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | Class II |
| ➤ Reference device 1 | |
| Sponsor | Guangdong Newdermo Biotech Co.,Ltd |
| Device Name and Model | LED light therapy mask (FM-01, FM-02, FM-03) |
| 510(k) Number | K223544 |
| Product Code | OHS, OLP, ILY |
| Regulation Number | 21 CFR 878.4810, 21 CFR 890.550 |
| Regulation Class | Class II |
| ➤ Reference device 2 | |
| Sponsor | NIGOBO HESI ELECTRIC CO., LTD |
| Device Name and Model | LED FACIAL LIGHT THERAPY MASK(Model:HK207) |
| 510(k) Number | K200983 |
| Product Code | OHS, OLP, ILY |
| Regulation Number | 21 CFR 878.4810, 21 CFR 890.5500 |
| Regulation Class | Class II |
(5) Description/ Design of device:
The LED Light Therapy Mask adopts light emitting diodes (LED) in the red (620mm±10mm), blue (460±10nm) and infrared (850nm=10nm) spectrum to irradiate on the face to realize its therapeutic effect. The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller (Only for SKB-2318L,SKB-2318PRO, IN-FM002,SKB-2418) is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.
(6) Indications for use:
LED Light Therapy Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
| (7) Materials | |||
|---|---|---|---|
| Component | Material of Component | Body Contact Category | Contact Duration |
6
| name | |||
|---|---|---|---|
| LED light | |||
| therapy mask | ABS, Silicone, Strap | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
7
(8) Technological characteristics and substantial equivalence:
The LED Light Therapy Mask has the same intenter. The technological characteristics such as wavelength and LED Power, are similar to the predicate device and reference devices. Any minor device and the listed predicate device and reference devices de vices do no raise any issues of safety or efficacy. Performance data supports that the device is safe predicate device and reference devices for its intended use.
Therefore, the LED Light Therapy Mask may be found substantially equivalent to its predicate device and reference devices.
| Item | Subject device | Predicate device 1 | Predicate device 2 | Reference device 1 | Reference device 2 | Remark | |
|---|---|---|---|---|---|---|---|
| Trade name | LED light therapy mask | Beauty LED Mask/Model: KFB265 | LED Facial Mask, Model(s):MZ-01, NEWKEY-01, SP-FM-01 | LED light therapy mask | LED FACIAL / LIGHT THERAPY MASK(Model:HK207) | / | |
| 510 (k) number | Applying | K221151 | K230351 | K223544 | K200983 | / | |
| Manufacturer | Shenzhen Siken Technology Co., Ltd. | Hunan Guangye Biotechnology Co., Ltd. | Shenzhen SUNGPO HI-TECH Electronic Co., Ltd | Guangdong Newdermo Biotech Co.,Ltd | NIGOBO HESI ELECTRIC CO., LTD | / | |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | |||
| 21 CFR 890.5500 | 21 CFR 878.4810 | ||||||
| 21 CFR 890.5500 | Same | ||||||
| Regulation Name | 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 Wrinkle and Acne Reduction | Light Based Over The Counter Wrinkle Reduction (OHS); | ||||
| Over-The-Counter Powered Light Based Laser For | Light Based Over The Counter Wrinkle Reduction (OHS); | ||||||
| Over-The-Counter Powered Light Based Laser For | Same | ||||||
| Acne(OLP); | |||||||
| Infrared, Therapeutic | |||||||
| Heating(ILY) | Acne(OLP); | ||||||
| Infrared, Therapeuti | |||||||
| c Heating(ILY) | |||||||
| Product code | OHS, OLP | OHS, OLP | OHS, OLP | OHS, OLP, ILY | OHS, OLP, ILY | Same | |
| Class | II | II | II | II | II | Same | |
| Indications for use/ | |||||||
| Intended use | LED Light Therapy Mask is | ||||||
| an over the counter device | |||||||
| that is intended to use LED | |||||||
| light for the treatment of | |||||||
| wrinkles and mild to | |||||||
| moderate acne. | The device is intended | ||||||
| to use LED light for the | |||||||
| treatment of wrinkles | |||||||
| and mild to moderate | |||||||
| acne. | 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. | 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 | The LED FACIAL | ||||||
| LIGHT THERAPY | |||||||
| MASK(Model:HK2 |
- 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
treatment of
full-face wrinkles. | Same | |
| | | | | circulation.
Mixed light:
Treatment of mild to
moderate
inflammatory acne. | | | |
| Location for
use | Face | Face | Face | Face and body | Entire Face and
body | Same | |
| OTC or
prescription | OTC | OTC | OTC | OTC | OTC | Same | |
| Power supply | Input: AC 100-240V 50-60Hz
0.3A
Output: DC 5V 1A
3.7V 650mAh
Li-ion Battery
3.7V1000mAh
Battery | Input:100-240V50/60 Hz, 50/60
Frequency: 50Hz/60Hz
Output: 5V 2A | An external adapter
Input: AC 100-240V
50-60Hz 0.2A
Output: DC 12V
0.5A | Input:
100-240 V
Hz, 0.25 A
Output: DC 5 V,
500 mA | Input:100-240Vac,
2.0A, 50/60Hz | Different
Note 1 | |
| Light source | Light Emitting Diodes
(LED) | Light Emitting Diodes
(LED) | Light Emitting
Diodes (LEDs) | Light Emitting
Diodes (LED) | Light Emitting
Diodes (LED) | Same | |
| Wavelength | SKB-1818P,SKB-1918,SKB-
1918P,SKB-1918PLUS:
Blue: 460nm ±10nm
Red: 620nm ±10nm
SKB-2318L,SKB-2318P,SKB
-2318PRO.IN-FM002.SKB-2 | Red (637nm ± 5nm)
and IR (854nm±5nm);
Blue (465±5nm) | Blue:465nm±5nm
Red: 625nm±5nm
Amber: 605nm ±
5nm | Red: 620nm
Blue: 460nm
Infrared: 850nm
Mixed: 620nm and
850nm and 460nm | 465nm,640nm,880n
m | Similar | |
| | 418: | | | | | | |
| | Blue: 460nm $\pm$ 10nm | | | | | | |
| | Red: 620nm $\pm$ 10nm | | | | | | |
| | Infrared: 850nm $\pm$ 10nm | | | | | | |
| LED Intensity | SKB-1818P:
Mode 1: Red: 5.5mW/cm²
Mode 2: Blue: 9mW/cm² | Red+IR:25.5mW/cm²
Blue: 1.36mW/cm² | Blue:15-63mW/cm²
Red:31-72mW/cm² | Red light: 2.03.0 mW/cm²4.0 mW/cm²
Blue light:2.0
Infrared light:
2.04.0 mW/cm²12.0 mW/cm² | 6.5mW/cm² | Different
Mixed light:
9.0
Note 2 | |
| | SKB-1918:
Mode 1: Red: 5mW/cm²
Mode 2: Blue: 6mW/cm² | | | | | | |
| | SKB-1918P:
Mode 1: Red: 6mW/cm²
Mode 2: Blue: 6.5mW/cm² | | | | | | |
| | SKB-1918PLUS:
Mode 1: Red: 3.5mW/cm²
Mode 2: Blue: 4.0mW/cm² | | | | | | |
| | SKB-2318L,SKB-2318P,SKB
-2318PRO,IN-FM002,SKB-2
418:
Mode 1: Red:
3.510mW/cm²8mW/cm² | | | | | | |
Mode 2: Blue:
2.5
| | Mode 3: Red+Infrared Light:
$6~27mW/cm^2$ | | | | | | |
| Treatment time | It is recommended to use it
for 10 minutes a day, 3 times
per week. | 10min each time | 10 minutes/day, 3
times per week | | Manual Mode:
15minutes each
time. | 3 times a week for
30min.
4 weeks | same |
| | | | | | Automatic Mode:
10minutes each
time.
3-4 treatment a
week, reduce to
1-2treatment a week
once the results
shown. | | |
| Dimensions
(mm) | Model
SKB-1818P,SKB-1918,
SKB-1918P:
194170131mm
Model SKB-1918PLUS:
217152173mm
SKB-2318L,SKB-2318P,SKB
-2318PRO,IN-FM002,SKB-2
418: 4111954mm | LED Mask:
Approximately 183mm
x 238mm x 98mm
Controller: 100mm x
50mm x 21.5mm | Not
available | publicly | FM-01:
20727743mm,
FM-02:
19838333.5mm,
FM-03:
237.51088.1mm | Not publicly
available | / |
| Weight | Model
SKB-1818P,SKB-1918,
SKB-1918P: 67g | | Not
available | publicly | Not publicly
available | Not publicly
available | / |
| | Model SKB-1918PLUS:
70g
SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002,SKB-2
418: 161g | | | | | | |
| Compliance
with voluntary
standards | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-11;
IEC 60601-2-57;
IEC 62471
IEC 62133-2 | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-11;
IEC 60601-2-57;
IEC 62471 | IEC 60601-1;
IEC 60601-1-2;
IEC 60601-1-11;
IEC 60601-2-57;
IEC 62471 | IEC 60601-1;
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 60601-1-11 | Same | |
| Biocompatibility feature | All body-contacting
materials are complied with
ISO10993-5, ISO 10993-10
and ISO 10993-23 | All body-contacting
materials are complied
with ISO10993-5 and
ISO 10993-10 | Complied with ISO
10993-1,
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 | |
8
9
10
11
12
Comparison in details:
Note 1:
The power supply of devices are very similar but not identical, the safety of the power adapter. The slight difference will not raise safety and effective issue.
Note 2:
The LED Intensity of these devices are different, and the subject device device and Reference device. And has passed 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 to
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the product come into conclusion.
(9) Non-clinical studies and tests performed:
The following performance data were provided in support of the substantial equivalence determination.
1) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
- ANSI AAMI ES 60601-1, Medical electrical equipments for basic safety and essential performance A
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic salety and esential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- A IEC 60601-1-11, Medical electrical equipments - 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
- A IEC 60601-2-57 Medical electrical equipments - Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use
- IEC 62133-2, Secondary cells and batteries ontaining alkaline or other non-acid electrolytes Safety requirements for portable sealed secondary cells, A and for batteries made from them, for use in portable applications - Part 2: Lithium systems
2) Eye Safety
- A IEC 62471 Photobiological safety of lamps and lamp systems
3) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the was conducted 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", as recognized by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity A
- ISO 10993-10:2021, Biological evaluation of medical devices –Part 10: Tests for skin sensitization A
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-
A ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation
We have also conducted: -
Software verification and validation test according to the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
(10) Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device LED Light Therapy Mask is found to be substantially equivalent to the Predicate devices.