Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine

K210545 · Marci Beauty, Inc. · OLP · May 20, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K210545
• Device Name: Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
• Applicant: Marci Beauty, Inc.
• Product Code: OLP · General, Plastic Surgery
• Decision Date: May 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only.

Device Story

Hand-held, over-the-counter phototherapy device for home use; utilizes red (625±5nm), blue (465nm), and infrared (850±5nm) LEDs to deliver light energy to the face. Device includes handpiece, charging base, and AC adapter. Operates by emitting uniform light spectrum; includes temperature stabilizer (40±2°C) and automatic 8-minute shut-off. User-operated by adults for wrinkle reduction and acne treatment. Output is light energy; healthcare providers do not interact with device output. Benefits include non-invasive treatment of skin conditions at home.

Clinical Evidence

No clinical data included. Bench testing only: verified compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471, ISO 14971, ISO 10993-5, and ISO 10993-10.

Technological Characteristics

Hand-held LED device; ABS plastic and aluminum head construction. Wavelengths: Blue 465nm, Red 620-630nm, IR 845-855nm. Power: 900mAh rechargeable Li-Ion battery. Features automatic 8-minute shut-off and temperature stabilizer (40±2°C). Standards: IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-57, IEC 62471, ISO 10993-5/10. Connectivity: None.

Indications for Use

Indicated for adults with facial wrinkles (red/infrared light) and mild to moderate inflammatory acne (blue light).

Regulatory Classification

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.

Predicate Devices

• Aduro Light Therapy Handheld (K203271)
• LED FACIAL LIGHT THERAPY MASK (Model: HK207) (K200983)
• Elevare Plus (K172909)
• Sapphire, Elevare Sapphire (K172555)

Submission Summary (Full Text)

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May 20, 2022

Marci Beauty Inc % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Mansion, Hangian Street, Lucheng District Wenzhou. Zhejiang 325000 China

Re: K210545

Trade/Device Name: Infrared Red Blue LED Light Heat Beauty Machine 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: OLP, OHS Dated: October 13, 2020 Received: February 25, 2021

Dear Helen Nan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210545

Device Name Infrared Red Blue LED Light Heat Beauty Machine

Indications for Use (Describe)

The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the blue light is intended for the treatment of the mild to moderate inflammatory acne.

This device is indicated for adults only.

| 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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## K210545 510(k) Summary

### 1.0 Submitter Information

| Company: | Marci Beauty Inc |
|------------------------|-----------------------------------------------------|
| Address: | 4290 Cameron st, Unit 7,<br>Paradise NV 89103, U.S. |
| Phone: | 086-180-26309981 |
| Contact Person: | Shaul Rappaport |
| E-mail: | [e-mail] |
| 2.0 Device Information | |

| Trade/Device Name: | Infrared Red Blue LED Light Heat Beauty Machine |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Model: | Vega; Jupiter; Neptune |
| Regulation Description: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology |
| Device: | Light Based Over The Counter Wrinkle Reduction;<br>Over-The-Counter Powered Light Based Laser For Acne |
| Common Name: | Acne and Wrinkle Light Therapy System |
| Product Code: | OLP, OHS |
| Review Panel: | General & Plastic Surgery |
| Submission Type: | 510(k) |
| Regulation Number: | 21 CFR 878.4810 |
| Device Class: | Class II |

#### 3.0 Predicate Device Information

| Device Name | 510K Number | Submitter |
|-------------------------------------------------|-------------|--------------------------------------|
| Aduro Light Therapy Handheld | K203271 | Shenzhen Kaiyan Medical CO LTD |
| LED FACIAL LIGHT<br>THERAPY MASK (Model: HK207) | K200983 | Ningbo Hesi Electric Co., Ltd |
| Elevare Plus | K172909 | Omm Imports d/b/a Zero Gravity |
| Sapphire, Elevare Sapphire | K172555 | Omm Imports, Inc. d/b/a Zero Gravity |

## 4.0 Device Description

The proposed device Infrared Red Blue LED Light Heat Beauty Machine, is a over-the-counter device hat uses low power light spectrum at red blue and infrared LED, at wavelength of 625±5nm, 465mm, 850±5nm emitting optical power in a uniform distribution.

The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C.charging adapter. It is a hand-held light emitting diode (LED) device for treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.

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## 5.0 Indications for Use

The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

This device is indicated for adults only.

## 6.0 Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device conforms to the following standards:

| Standard | Title |
|----------------|-------------------------------------------------------------------|
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for |
| | Basic Safety and Essential Performance |
| | Medical electrical equipment - Part 1-2: General requirements for |
| IEC 60601-1-2 | basic safety and essential performance - Collateral Standard: |
| | Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-11 | Medical Electrical Equipment - Part 1-11: General Requirements |
| | for Basic Safety and Essential Performance - Collateral Standard: |
| | Requirements for Medical Electrical Equipment and Medical |
| | Electrical Systems Used in the Home Healthcare Environment |
| IEC 60601-2-57 | Medical electrical equipment - Part 2-57: Particular requirements |
| | for the basic safety and essential performance of non-laser light |
| | source equipment intended for therapeutic, diagnostic, monitoring |
| | and cosmetic/aesthetic use |
| IEC 62471 | Photobiological safety of lamps and lamp systems |
| ISO 14971 | Application of risk management to medical devices |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for In |
| | Vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for |
| | irritation and skin sensitization |

## 7.0 Clinical Test Conclusion

Clinical data was not including in this submission.

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#### 8.0 Substantial Equivalence

The Infrared Red Blue LED Light Heat Beauty Machine is substant with the legally marketed device. The Infrared Red Blue LED Light Heat Beauty Machine have been tested for biocompatibility, electrical safety, and other physical performance as documented above and meet or exceed the applicable requirements of the recated standards and therefore the proposed product is as safe and as effective for it's intended use.

The table below shows similarities and differences between the predicate device and the subject device.

| Device | Subject Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | Predicate Device #4 |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Infrared Red Blue LED Light Heat Beauty Machine | Aduro light therapy Handheld | The LED FACIAL LIGHT THERAPY MASK | Elevare Plus | SAPPHIRE |
| | | | | | |
| | | | | | |
| 510k number | K210545 | K203271 | K200983 | K172909 | K172555 |
| Classification | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Product code | OHS,OLP | OHS,OLP | OHS,OLP | OHS | OLP |
| Use | OTC | OTC | OTC | OTC | OTC |
| Model | Vega; Jupiter; Neptune | HD-03A | HK207 | - | - |
| Indication for Use | The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the | The Aduro light therapy Handheld (Model: HD-03A), the red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate | The LED FACIAL LIGHT THERAPY MASK is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting | The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face. | The SAPPHIRE is an over - the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use |
| | | inflammatory acne. | | | in the treatment of |
| | blue light is intended<br>for the treatment of the<br>mild to moderate<br>inflammatory acne.<br>This device is<br>indicated for adults<br>only. | | energy in the red and<br>infrared spectrum is<br>intended for the<br>treatment of full-face<br>wrinkles. | | mild to moderate<br>inflammatory acne. |
| Anatomical<br>Sites | Entire Face | Entire Face | Entire Face and Body | Entire Face | Entire Face |
| Design | Hand-held Type | Hand-held Type | Face-wear Type | Hand-held device | Hand-held device |
| Target<br>Population | Adult with wrinkles on<br>face;<br>Adult with mild to<br>moderate<br>inflammatory acne | Individuals with<br>periorbital wrinkles on<br>face, Individuals<br>with mild to moderate<br>inflammatory acne | Adult with wrinkles on<br>face;<br>Adult with mild to<br>moderate<br>inflammatory acne | Individuals with<br>wrinkles on face | Adult with mild to<br>moderate inflammatory<br>acne |
| The distance<br>between the<br>LEDs to<br>treatment<br>surface | 2 - 3 cm | Does not directly<br>contact the patient;<br>approximately 2-6<br>inches | 0.5 - 3 cm | Direct contact | Direct contact |
| Treatment<br>regimen | 3 times a week for 30<br>min. 4 weeks | 3-5 minutes on each<br>treatment area.<br>For best results 3-5<br>times per week with 2<br>day rest. | 3 times a week for 30<br>min. 4 weeks | 3 minutes daily, 5 days<br>per week for 8 weeks | 4 minutes per area,<br>twice per week for 4<br>weeks (total of 8<br>treatments) |
| Device | Subject Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | Predicate Device #4 |
| Wavelengths | Blue: 465nm<br>Red: 620-630nm<br>IR: 845-855nm | Blue: 415 $\pm$ 10nm<br>Red: 630 $\pm$ 10nm<br>IR: 850nm | Blue: 465nm<br>Red: 640nm<br>IR: 880nm | Red: 610nm, 630nm,<br>660nm<br>IR: 850 $\pm$ 5nm | Blue: 415 $\pm$ 5nm |
| Main Unit<br>Weight | 265g | 135g $\pm$ 2g | Not publicly available | 150g | Not publicly available |
| Housing<br>Materials of<br>main unit | ABS Plastic and<br>Aluminum Head | ABS Plastic | biocompatible material | GLASS PROBE<br>(HEAD) | GLASS PROBE<br>(HEAD) |
| Power Supply | 900mAh,<br>Rechargeable Li-Ion<br>batteries | 2600mAh,<br>3.7V Li battery | Input: 100 - 240Vac,<br>2.0 A, 50/60Hz | 2 Li-Ion<br>rechargeable<br>batteries | rechargeable Li-Ion<br>batteries |
| Electrical<br>power | 100~240V AC<br>50/60HZ 0.5A | Not publicly available | Input: 100 - 240Vac,<br>2.0 A, 50/60Hz | 100~240V AC<br>50/60HZ 0.35A | 100~240V AC<br>50/60HZ 0.7A |
| Energy Source | 24 LEDs | Not publicly available | Not publicly available | 25 LEDs | Not publicly available |
| Intensity<br>(mW/cm²) | Blue Light Mode: 5.4<br>Red Light Mode: 7.2 | Blue: 20-65<br>Red: 40-80 | 6.5 | 65 $\pm$ 5 | 50 |
| Software | Yes | Yes | Yes | Yes | Yes |
| Automatic<br>Shut Off | Yes<br>8 Minutes | Yes<br>3 Minutes | Not publicly available | Yes | Yes |
| Temperature<br>stabilizer | 40 $\pm$ 2°C | Not publicly available | Not publicly available | 41 $\pm$ 2°C | 40-42 °C |

#### Table 1 -General Comparison

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Table 2 - Performance Comparison

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| Device | Subject Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | Predicate Device #4 |
|---------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------|
| Electric Safety | Comply with IEC<br>60601-1,<br>IEC 60601-1-11 | Not publicly available | Comply with IEC<br>60601-1,<br>IEC 60601-1-11 | Comply with IEC<br>60601-1,<br>IEC 60601-1-11 | Comply with IEC<br>60601-1,<br>IEC 60601-1-11 |
| Photobiological<br>Safety | Comply with IEC<br>62471 | Not publicly available | Not publicly available | Comply with IEC<br>62471 | Comply with IEC<br>62471 |
| EMC | Comply with IEC<br>60601-1-2 | Not publicly available | Comply with IEC<br>60601-1-2 | Comply with IEC<br>60601-1-2 | Comply with IEC<br>60601-1-2 |
| Bioconpatibility | Comply with ISO<br>10993-1,<br>ISO 10993-5 and ISO<br>10993-10 | Comply with ISO<br>10993-1,<br>ISO 10993-5 and ISO<br>10993-10 | Comply with ISO<br>10993-1,<br>ISO 10993-5 and ISO<br>10993-10 | Comply with ISO<br>10993-1,<br>ISO 10993-5 and ISO<br>10993-10 | Comply with ISO<br>10993-1,<br>ISO 10993-5 and ISO<br>10993-10 |

Table 3-Safety Comparison

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### 9.0 Conclusion

Taking into consideration the table for substantial equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the proposed device raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device.