(101 days)
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.
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.
The provided document is a 510(k) premarket notification for cosmetic devices (LED light therapy for wrinkle reduction and acne treatment), not a medical device requiring clinical studies with AI, human readers, or complex ground truth establishment. Therefore, most of the requested information regarding AI performance, expert consensus, and multi-reader studies is not applicable.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
Here's an assessment based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the format of a table with numerical thresholds for performance. Instead, it outlines the non-clinical tests performed to ensure safety and effectiveness, assuming compliance with these standards serves as the acceptance criteria.
| Acceptance Criteria Category | Reported Device Performance Summary (Implicit Compliance) |
|---|---|
| Electrical Safety (EMC) | Compliant with IEC 60601-1-2 |
| General Safety and Essential Performance | Compliant with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57 (for non-laser light source equipment), IEC 62471 (Photobiological safety) |
| Battery Safety | Compliant with IEC 62133-2 (for Lithium systems) |
| Biocompatibility | Compliant with ISO 10993-1, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and skin sensitization), ISO 10993-23 (Irritation) |
| Software Verification and Validation | Performed and documented per FDA guidance ("Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff"). Software considered "Basic Documentation Level," indicating malfunction would likely lead to minor injury. |
| Usability Validation | Compliant with IEC 62366-1 and IEC 60601-1-6 |
| Irradiance & Wavelength | Wavelengths are specified (e.g., Red 630±10nm, Blue 415±10nm, Yellow 590±10nm, IR 830±10nm). Irradiance values are provided for different models and light modes (e.g., HD-59A Total: 75~115 mW/cm²). The document states, "Although the irradiance differs from ins within the acceptable deviation range; therefore, this difference will not raise any effectiveness issues." This implies the measured irradiance values fall within an accepted range for the intended effect. |
| Treatment Time | Specified as 2 minutes per treatment. |
| Material/Design equivalence | Materials comply with requirements. Housing materials differ from predicates but comply with requirements. Power source and treatment time slightly differ from predicates but comply with requirements. |
2. Sample sizes used for the test set and the data provenance
The document primarily describes non-clinical performance testing (electrical safety, biocompatibility, software validation, usability validation). These tests are typically conducted on device prototypes or production samples rather than human test subjects in the context of a clinical study for AI model validation. Therefore, there isn't a "test set" in the sense of patient data.
- Sample size for non-clinical tests: Not explicitly stated as a number of devices, but typically involves a limited number of test units to demonstrate compliance with standards.
- Data Provenance: Not applicable in the context of patient data. The tests are performed on the device itself. The document mentions Shenzhen Nuon Medical Equipment Co., Ltd as the manufacturer in China, so the testing would likely have occurred there or at a certified lab contracted by them.
- The document explicitly states: "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." This confirms that no patient data was used for a clinical "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As clinical testing was not performed, there was no patient data requiring expert ground truth establishment for the test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication of findings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a direct-to-consumer cosmetic LED light therapy product, not an AI-assisted diagnostic or therapeutic device requiring MRMC studies for human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no AI algorithm in this device, as described, that would require standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this specific device, "ground truth" refers to the established technical standards (e.g., IEC, ISO) and the device's ability to meet those specifications (e.g., emitting light at specified wavelengths and irradiance, safe electrical operation, biocompatible materials).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; hence, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set for an AI model.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
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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.
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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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{5}------------------------------------------------
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{6}------------------------------------------------
| Predicate Device 6 (K241293)Sponsor: YASSEN WELLNESS LLCTrade Name: LED Light Therapy Device, ELIXIR MDTMClassification Name: Powered Laser Surgical InstrumentReview Panel: General & Plastic SurgeryProduct Code: GEXRegulation Number: 21 CFR 878.4810Regulation Class: II |
|---|
| 4. Device DescriptionThe 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 UseThe 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 |
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| 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, 0.204WhFor model HD-70:3.7V, 95mAh, 0.3515Wh | 5-15V DC 2.5A maxpowered by 2 Li-IonBatteries 3.7V1500mAh | Lithium battery:3.6V,65mAh, 0.234Wh | Adapter input: 5V 0.5AInternal battery:3.7V/600mAh | Input: 100 -240 V, 50/60 HzOutput: 5V, 1ALithium 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 deviceis not sold sterile | Not applicable - thisdevice is not sold sterile | Not applicable - thisdevice is not sold sterile | Not applicable - thisdevice is not sold sterile | Not applicable — this deviceis not sold sterile | Not applicable - this deviceis not sold sterile | Not applicable - this deviceis not sold sterile |
| LED | LED | LED | LED | LED | LED | LED |
| HD-59A: Red+IR630±10nm&830±10nm | Different,note 2 | |||||
| HD-59B: Yellow 590±10nm | Same | |||||
| HD-59D: Blue 415±10nm | Same | |||||
| HD-70:Red+IR light mode630±10nm&830±10nm | Red: 633 ±10nmBlue: 415 ±10nm | Blue: 415 ± 10nm,Red: 630 ± 10nm | Same | |||
| Yellow light mode:590±10nm | Amber: 605±10nm | Red: 630~640nm | ||||
| Blue light mode:415±10nm | Red: 630±10nm | IR:845 | ||||
| HD-72:Red light mode:630±10nm | MT-12MA:Red: 630 ± 10nmBlue: 415 ± 10nm | RBY irradiator:Red: 633 ± 10nm,Blue: 417± 10nm,Yellow: 590±10nm | ||||
| Yellow light mode:590±10nm | MT-12MC:Infrared:830 ± 10nmRed: 630 ± 10nmYellow:590± 10nmBlue: 415 ± 10nm | RBI irradiator:Red 633 ±10nmBlue 417 ± 10nmIR 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: 5415nm: 25630+415nm: 30 | Amber light mode:605±10nm: 15Red light mode:630±10nm: 2.5Blue light mode:415±10nm: 1.4 | Red light mode : 25IR light mode:3Red+IR mode: 30Blue mode: 18Amber mode: 20Mix light mode: 9 | Red: 20 |
|---|---|---|---|---|---|
| HD-73B: Blue 415±10nm | Blue light mode:415±10nm:64±5 | For MT-12MC:630nm(type 1): 5415nm: 25Mode 1 - total: 30830nm: 15630nm (type 2): 20Mode 2 - total: 35Mode 3 - 590nm: 35 | |||
| HD-116:Red light mode:630±10nm | Blue light mode:415nm: 20 | ||||
| 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+IR630±10nm: 45 | |||||
| HD-59B: Yellow590±10nm:10~30 | |||||
| HD-59D: Blue415±10nm: 35~50 | |||||
| HD-70:Red+IR light mode:Red 630±10nm: 45 | IR 830±10nm:55+5 | ||||
| Yellow light mode:590±10nm:10~30 | Total: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 |
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| Treatment time | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 minutes per treatment | LED: 3 minutes eachlight mode for a total of9 minutes pertreatment,recommended to use 2to 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 2630+830nm):9 minutes per treatment | For MT-12MC(mode 3590nm):21 minutes pertreatment | Unknown | For red, blue andred+infrared: 10, 20,30 minutesFor infrared, amberlight and mixed light:10, 20 minutes. | 3 minutes per treatment | 20min (Recommendedtreatment time) | Different,note 2 | |
| Software/Firmware/Microprocessorcontrol? | 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 withIEC 60601-1,IEC 60601-1-11,IEC 62471,IEC 60601-2-57 | Compliant withIEC60601-1, IEC60601-1-11,IEC62471,IEC 60601-2-57 | Compliant withIEC 60601-1,IEC 62471,IEC 60601-2-57,IEC 60601-1-11 | Compliant withIEC 60601-1,IEC 60601-2-83 | Compliant withIEC 60601-1,IEC 60601-1-11,IEC60601-2-83 | Compliant withIEC 60601-1,IEC 60601-1-11,IEC 62471 | Compliant withIEC 60601-1,IEC60601-2-57,IEC 60601-1-11 | Compliant withIEC 60601-1,IEC60601-2-57 | Compliant withIEC 60601-1,IEC60601-2-57 | Compliant withIEC 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
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| 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 validationSoftware 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 PerformanceClinical 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.ConclusionThe 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. |
§ 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.