(101 days)
Not Found
No
The device description focuses on light emission for treatment and basic controls (on/off, mode switching, auto-shutoff). There is no mention of any features that would require AI or ML, such as image analysis, personalized treatment adjustments, or learning from user data.
Yes
The device is intended for the treatment of wrinkles and mild to moderate inflammatory acne, which are therapeutic claims.
No
The device is intended for treatment (wrinkle reduction and acne treatment) using light emission, not for diagnosing conditions or diseases.
No
The device description clearly states it is a hand-held, rechargeable device powered by a lithium-Ion battery that emits light for treatment. This indicates it is a physical hardware device, 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 is for the treatment of wrinkles and acne, which are cosmetic and therapeutic purposes. IVDs are used to diagnose diseases or conditions.
- Device Description: The device uses light therapy (red, infrared, yellow, and blue light) to achieve its intended effects. This is a physical treatment method, not a diagnostic test that analyzes biological samples.
- Lack of Diagnostic Elements: There is no mention of the device analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
- Over-the-Counter Cosmetic Use: The intended user is the general public for cosmetic purposes, not healthcare professionals for diagnostic purposes.
Therefore, the Radiant Renewal Skincare Lid is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Radiant Renewal Skincare Lid (Model: HD-59A. HD-72, HD-73A. HD-116. HD-53A) is intended for the treatment of wrinkles for over-the-counter cosmetic use.
The Radiant Renewal Skincare Lid (Model: HD-70) is intended for the treatment of wrinkles and the mild to moderate inflammatory acne for over-the-counter cosmetic use.
The Radiant Renewal Skincare Lid (Model: HD-59D, HD-72A, HD-73B,HD-116A,HD-53B) is intended for the treatment of the mild to moderate inflammatory acne for over-the-counter cosmetic use.
Product codes
OHS, OLP
Device Description
The Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) is a hand-held, rechargeable device powered by a lithium-Ion battery, designed for single-patient use. It offers wrinkle reduction through the emission of red light (wavelength: 630nm±10nm) and infrared light (wavelength: 830nm±10nm) and yellow light (wavelength: 630nm±10nm), and acne treatment through the emission of blue light(wavelength: 415nm±10nm).
There are 12 models of the device, each with similar core functionalities, but differing in the specific light treatments and additional features they offer.
Model HD-59A offers red and infrared light for wrinkle treatment, model HD-59B provides yellow light for wrinkle treatment, and model HD-59D uses blue light for acne treatment. These three models differ only in the light treatments they offer.
Model HD-70 features three treatment modes: mode 1: Red light and infrared light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction; mode 3: Blue light for acne treatment.
Models HD-72, HD-73A, and HD-116 offer two treatment modes: mode 1: Red light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction;
Models HD-72A, HD-73B, and HD-116A provide only blue light for acne treatment.
The difference between HD-72 and HD-72A, HD-73A and HD-73B, and HD-116 and HD-116A lies in the light treatments they offer. Apart from this, the HD-72 series, HD-73A series, and HD-116 series differ only in appearance.
Model HD-53A offers only red light for wrinkle treatment while model HD-53B provides only blue light for acne treatment.
The package includes the main unit, a charging cable, a user manual, a tray and a cosmetic container(only for model HD-70). An optional squeeze tube is also available but not included by default. Except for model HD-70, which features an additional rotating rock button, other models are equipped with a single button to turn the device on or off and switch treatment modes. The device can also be used with other skincare products such as face creams, eye creams, serums, etc.
The device will automatically shut down after the recommended duration of 2 minutes. If you wish to continue the treatment, simply press the button to turn the device back on.
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 cosmetic 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)
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.
Non-Clinical Tests Performed:
Electrical safety, and electronical or and to assure conformance with the filoming vuluntary design standards in cone edical avoice added a ledica
IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11 Edition 2.1 2020-07 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 Edition 2.0 2023-01 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 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.
IEC 62133-2 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
Biocompatibility Test:
ISO 10993-1: 2018 Fifth Edition Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management.
ISO 10993-5: 2009 Third Edition Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10: 2021 Third Edition Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-23: 2021 First Edition Biological evaluation of medical devices- Part 23: Tests for irritation.
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, "Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff." The software for this device was considered as a Basic Documentation Level, 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.
Usability validation:
IEC 62366-1: 2015+AMD1:2020 Edition 1.1 Medical devices - Part 1: Application of usability engineering to medical devices.
IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020 CSV Edition 3.2 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K230293, K240089, K241718, K241857, K203271, K241293
Reference Device(s)
Not Found
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.
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2024
Shenzhen Nuon Medical Equipment Co., Ltd Alain Dijkstra CEO 1st Floor-3rd Floor, No. 27-2, Xintang Rd, Xintian Community Fuhai Street, Baoan District Shenzhen, Guangdong 518000 China
Re: K242700
Trade/Device Name: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) 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 4, 2024 Received: September 9, 2024
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/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.
1
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.
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 (OS) 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.
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.
2
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 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,
TANISHA L Digitally signed by
TANISHA L. TANISHA L. HITHE -S HITHE -S ===================================================================================================================================================================== 12:21:50 -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
510(k) Number (if known) K242700
Device Name
Radiant Renewal Skincare Lid (Model: HD-59A, HD-72, HD-73A, HD-116, HD-53A, HD-70, HD-59D, HD-72A, HD-72A, HD-73B,HD-116A,HD-53B)
Indications for Use (Describe)
The Radiant Renewal Skincare Lid (Model: HD-59A. HD-72, HD-73A. HD-116. HD-53A) is intended for the treatment of wrinkles for over-the-counter cosmetic use.
The Radiant Renewal Skincare Lid (Model: HD-70) is intended for the treatment of wrinkles and the mild to moderate inflammatory acne for over-the-counter cosmetic use.
The Radiant Renewal Skincare Lid (Model: HD-59D, HD-72A, HD-73B,HD-116A,HD-53B) is intended for the treatment of the mild to moderate inflammatory acne for over-the-counter cosmetic use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
700 - 510(k) Sum
summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR
Submither Selument Co., Ltd
Submit Negletralion, Medial Euulphen Co., Ltd
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Restration Marci Light Back Core Tre Counter Power Light Besof Last Por Are-116, HD-116A, HD-118A, HD-118A, HD-118A, HD-118A, HD-118A, HD-118A,
e - Predicate Device Information
Sportson The Fridad Walliam
Prade Manier The Masting Counter Wrinkle Redul
Production Themal List Massil
Produkt Polali Olehoral Copyright
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5
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Articles Patines Minder Light Based Control Com Counter Powered Light Based Laser P
Salifrain Name Light Based Over the Counter Winkle Reduction:
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astiliation Micror Light Praceded Prove AM-810W, AM-812D, AM-812W,
Asteriorion Light Praced Overy Pounter Writing Reduction, Ove
redite Bovee 4 (CA41457)
Maria Maria (LB1) (Periodop, CO221) KE2285, KEB283)
Sealines (LB1) (Page CO910) KEE288, KEB283)
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Pealieae Bavice & Kc302711
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6
| Predicate Device 6 (K241293)
Sponsor: YASSEN WELLNESS LLC
Trade Name: LED Light Therapy Device, ELIXIR MDTM
Classification Name: Powered Laser Surgical Instrument
Review Panel: General & Plastic Surgery
Product Code: GEX
Regulation Number: 21 CFR 878.4810
| Regulation Class: II |
|---|
| 4. Device Description |
| The Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) is a hand-held, rechargeable device powered by a lithium-Ion battery, designed for single-patient use. It offers wrinkle reduction through the emission of red light (wavelength: 630nm±10nm) and infrared light (wavelength: 830nm±10nm) and yellow light (wavelength: 630nm±10nm), and acne treatment through the emission of blue light(wavelength: 415nm±10nm). |
| There are 12 models of the device, each with similar core functionalities, but differing in the specific light treatments and additional features they offer. |
| Model HD-59A offers red and infrared light for wrinkle treatment, model HD-59B provides yellow light for wrinkle treatment, and model HD-59D uses blue light for acne treatment. These three models differ only in the light treatments they offer. |
| Model HD-70 features three treatment modes: mode 1: Red light and infrared light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction; mode 3: Blue light for acne treatment. |
| Models HD-72, HD-73A, and HD-116 offer two treatment modes: mode 1: Red light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction; |
| Models HD-72A, HD-73B, and HD-116A provide only blue light for acne treatment. |
| The difference between HD-72 and HD-72A, HD-73A and HD-73B, and HD-116 and HD-116A lies in the light treatments they offer. Apart from this, the HD-72 series, HD-73A series, and HD-116 series differ only in appearance. |
| Model HD-53A offers only red light for wrinkle treatment while model HD-53B provides only blue light for acne treatment. |
| The package includes the main unit, a charging cable, a user manual, a tray and a cosmetic container(only for model HD-70). An optional squeeze tube is also available but not included by default. Except for model HD-70, which features an additional rotating rock button, other models are equipped with a single button to turn the device on or off and switch treatment modes. The device can also be used with other skincare products such as face creams, eye creams, serums, etc. |
| The device will automatically shut down after the recommended duration of 2 minutes. If you wish to continue the treatment, simply press the button to turn the device back on. |
| 5. Intended Use / Indications for Use |
| The Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-72, HD-73A, HD-116, HD-53A) is intended for the treatment of wrinkles for over-the-counter cosmetic use |
The Radiant Renewal Skincare Lid (Model. HD-70) is intended for the mild to moderate inflammator acre for over-the-counter cosmeti
use.
The Radiant Renewal Skincere Lid (Model: HD-59D, HD-116A, HD-53B) is intended for the treatment of the mild to moderate inflammatory acre for
over the counter osse.
7
Comparison to predicate devices.
- Companson to predicate devices
Compare with the predicate devices is very simlar in design principle, indications for use, findions, naterial and the applicable
| Elements of Comparison | Subject device (K242700) | Predicate device 1 (K230293) | Predicate device 2 (K240089) | Predicate device 3 (K241718) | Predicate device 4 (K241857) | Predicate device 5 (K203271) | Predicate device 6 (K241293) | Remark |
|---|---|---|---|---|---|---|---|---|
| Manufacturer | Shenzhen Nuon Medical Equipment Co., Ltd | THERABODY, Inc. | Shenzhen Kaiyan Medical Equipment Co., Ltd | Shenzhen Aozemei Technology Co. Ltd | Dongguan Boyuan Intelligent Technology Co., Ltd. | Shenzhen Kaiyan Medical Equipment Co., Ltd | YASSEN WELLNESS LLC | |
| 510 (K) Number | K242700 | K230293 | K240089 | K241718 | K241857 | K203271 | K241293 | -- |
| Device Name | Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) | TheraFace Mask | Face Patches(MT-12MA, MT-12MC) | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Aduro light therapy Handheld(Model:HD-03A,HD-25A, HD-07A) | LED Light Therapy Device, ELIXIR MD ™ | -- |
| Regulation Class | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Same |
| Product Code | OHS,OLP | OHS | OHS, OLP, GEX | OHS, OLP | OHS, OLP,ILY | OHS, OLP | GEX | Same |
| Intended Location Use | Face | Face | Face | Face | Face | Face | Face | Same |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
8
9
| Lithium battery:
For models HD-59A,
HD-59B,HD-59D,HD-72,
HD-72A,HD-73A,
HD-73B,HD-116,HD-116A,
HD-53A,HD-53B:
3.7V, 55mAh, 0.204Wh
For model HD-70:
3.7V, 95mAh, 0.3515Wh | 5-15V DC 2.5A max
powered by 2 Li-Ion
Batteries 3.7V
1500mAh | Lithium battery:3.6V,
65mAh, 0.234Wh | Adapter input: 5V 0.5A
Internal battery:
3.7V/600mAh | Input: 100 -240 V, 50/60 Hz
Output: 5V, 1A
Lithium ion battery:
1300mAh | For HD-03A: 2600mAh,
3.7V Li battery;
For HD-25A: 2600mAh,
3.7V Li battery;
For HD-07A: 160mAh,
3.7V Li battery | AC 100-240 50/60Hz |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Not applicable - this device
is not sold sterile | Not applicable - this
device is not sold sterile | Not applicable - this
device is not sold sterile | Not applicable - this
device is not sold sterile | Not applicable — this device
is not sold sterile | Not applicable - this device
is not sold sterile | Not applicable - this device
is not sold sterile |
| LED | LED | LED | LED | LED | LED | LED |
| HD-59A: Red+IR
630±10nm&830±10nm | | | | | | Different,
note 2 |
| HD-59B: Yellow 590±10nm | | | | | | Same |
| HD-59D: Blue 415±10nm | | | | | | Same |
| HD-70:
Red+IR light mode
630±10nm&830±10nm | Red: 633 ±10nm
Blue: 415 ±10nm | | | | Blue: 415 ± 10nm,
Red: 630 ± 10nm | Same |
| Yellow light mode:
590±10nm | | | Amber: 605±10nm | Red: 630640nm | | |855nm
| Blue light mode:
415±10nm | | | Red: 630±10nm | IR:
845
Blue:
460~470nm
Amber:
600~610nm | | |
| HD-72:
Red light mode:
630±10nm | | MT-12MA:
Red: 630 ± 10nm
Blue: 415 ± 10nm | | | RBY irradiator:
Red: 633 ± 10nm,
Blue: 417± 10nm,
Yellow: 590±10nm | |
| Yellow light mode:
590±10nm | | MT-12MC:
Infrared:830 ± 10nm
Red: 630 ± 10nm
Yellow:590± 10nm
Blue: 415 ± 10nm | | | RBI irradiator:
Red 633 ±10nm
Blue 417 ± 10nm
IR 835 ± 15nm | |
| HD-72A: Blue 415±10nm | | | | | | |
| HD-73A:
Red light mode:
630±10nm | | | | | | |
10
| Yellow light mode:
590±10nm | Red light mode:
633±10nm:
73±5 | For MT-12MA:
630nm: 5
415nm: 25
630+415nm: 30 | Amber light mode:
605±10nm: 15
Red light mode:
630±10nm: 2.5
Blue light mode:
415±10nm: 1.4 | Red light mode : 25
IR light mode:3
Red+IR mode: 30
Blue mode: 18
Amber mode: 20
Mix light mode: 9 | Red: 2096120
Blue: 10
Yellow(590±10nm): 53565
IR: ≤ 70
Red/IR: 166
Blue/IR: 190
Different, note 3 |
|-------------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| HD-73B: Blue 415±10nm | Blue light mode:
415±10nm:
64±5 | For MT-12MC:630nm
(type 1): 5
415nm: 25
Mode 1 - total: 30
830nm: 15
630nm (type 2): 20
Mode 2 - total: 35
Mode 3 - 590nm: 35 | | | |
| HD-116:
Red light mode:
630±10nm | | | | Blue light mode:
415nm: 20
Red light mode:
630nm: 4080 | |65
| Yellow light mode:
590±10nm | Red+IR light mode:
Red 633±10nm:
73±5 | | | | |
| HD-116A: Blue 415±10nm | | | | | |
| HD-53A: Red 630±10nm | | | | | |
| HD-53B: Blue 415±10nm | | | | | |
| HD-59A:Red+IR
630±10nm: 45
830±10nm: 3050115 | | | | | |
Total:75
| HD-59B: Yellow
590±10nm:1030 | | | | | |50 | | | | | |
| HD-59D: Blue
415±10nm: 35
| HD-70:
Red+IR light mode:
Red 630±10nm: 456550
IR 830±10nm: 30
Total:75115 | IR 830±10nm:30 | Total:
55+5 | | | | |
| Yellow light mode:
590±10nm:10
128±5 | | | | |
| Blue light mode: 415±10nm:
35~50 | | | | | |
| Irradiance
(mW/cm²) | | | | | |
7 / 10
11
| HD-72 | |
|---|---|
| Red light mode: | 630±10nm: 15~40 |
| Yellow light mode: | 590±10nm: 8~30 |
| HD-72A: | Blue 415±10nm: 35~50 |
| HD-73A | |
| Red light mode: | 630±10nm: 15~40 |
| Yellow light mode: | 590±10nm: 8~30 |
| HD-73B: | Blue 415±10nm: 35~50 |
| HD-116 | |
| Red light mode: | 630±10nm: 15~40 |
| Yellow light mode: | 590±10nm: 8~30 |
| HD-116A: | Blue 415±10nm: 35~50 |
| HD-53A: | Red 630±10nm: 20~40 |
| HD-53B: | Blue 415±10nm: 35~50 |
12
| Treatment time | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 minutes per treatment | LED: 3 minutes each | ||||||||||
| light mode for a total of | |||||||||||
| 9 minutes per | |||||||||||
| treatment, | |||||||||||
| recommended to use 2 | |||||||||||
| to 5 times per week | For MT-12MA | ||||||||||
| (630+415nm): | |||||||||||
| 3 minutes per treatment | For MT-12MC | ||||||||||
| (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):21 minutes per | |||||||||||
| treatment | Unknown | For red, blue and | |||||||||
| red+infrared: 10, 20, | |||||||||||
| 30 minutes | |||||||||||
| For infrared, amber | |||||||||||
| light and mixed light: | |||||||||||
| 10, 20 minutes. | 3 minutes per treatment | 20min (Recommended | |||||||||
| treatment time) | Different, | ||||||||||
| note 2 | |||||||||||
| Software/ | |||||||||||
| Firmware/ | |||||||||||
| Microprocessor | |||||||||||
| control? | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Same | |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | IEC60601-1-2 | Same | |
| Safety | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC 60601-1-11, | |||||||||||
| IEC 62471, | |||||||||||
| IEC 60601-2-57 | Compliant with | ||||||||||
| IEC60601-1, IEC60601- | |||||||||||
| 1-11, | |||||||||||
| IEC62471, | |||||||||||
| IEC 60601-2-57 | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC 62471, | |||||||||||
| IEC 60601-2-57, | |||||||||||
| IEC 60601-1-11 | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC 60601-2-83 | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC 60601-1-11, | |||||||||||
| IEC60601-2-83 | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC 60601-1-11, | |||||||||||
| IEC 62471 | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC60601-2-57, | |||||||||||
| IEC 60601-1-11 | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC60601-2-57 | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC60601-2-57 | Compliant with | ||||||||||
| IEC 60601-1, | |||||||||||
| IEC60601-2-57 | Same |
t: Although the housing materials of the subject device differ from those of the predicate evices all materials comply with the requirem
2 : Although the power source and treatment ime of the slightly from those of the preciseate devices, all compy with the requirement
te 3: Although the irradiance differs from ins within the acceptable deviation range; therefore, this difference will not raise any effectiveness issues
Test Summary
Nor-Clinical Tests Performed
Electrial astery, and electronical or and to assure conformance with the filoming vuluntary design standards in cone
edical avoice added a ledica
IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
13
| IEC 60601-1-11 Edition 2.1 2020-07 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 Edition 2.0 2023-01 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 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems. IEC 62133-2 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems. |
|---|
| 2) Biocompatibility Test ISO 10993-1: 2018 Fifth Edition Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management. ISO 10993-5: 2009 Third Edition Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. ISO 10993-10: 2021 Third Edition Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. ISO 10993-23: 2021 First Edition Biological evaluation of medical devices- Part 23: Tests for irritation. |
| 3) 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, "Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff." The software for this device was considered as a Basic Documentation Level, 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. |
| 4) Usability validation IEC 62366-1: 2015+AMD1:2020 Edition 1.1 Medical devices - Part 1: Application of usability engineering to medical devices. IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020 CSV Edition 3.2 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. |
| 7.2 Summary of Clinical Performance |
| 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. |
| 8. Date of the summary prepared: December 14, 2024 |
| 9.Conclusion |
| The proposed device use technology that is similar to the predicate devices. The technology and design do not raise new types of questions regarding safety and effectiveness for the proposed indications for use and the performance testing supports that the device can be used safely and effectively for the proposed indications for use. The proposed device is considered to be substantially equivalent to the predicate device K230293, K240089, K241718, K241857, K203271 and K241293. |