LED Spectrum therapy instrument

K231894 · Shenzhenshi Sincoheren S&T Development Co., Ltd. · GEX · Sep 20, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231894
• Device Name: LED Spectrum therapy instrument
• Applicant: Shenzhenshi Sincoheren S&T Development Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LED Spectrum therapy instrument includes five models, which are PDT-I, PDT-J, PDT-K, PDT-L, PDT-M. PDT-I: Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-J: Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied. Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-K: Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatment of mild to moderate inflammatory acne. PDT-L: Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. PDT-M: Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Device Story

Portable LED therapy device; uses specific light wavelengths (Red 630nm, Blue 420nm, Yellow 590nm, Infrared 825nm) to treat dermatological conditions and provide topical heating. Components include stand, therapeutic head, color touch screen, and power supply. Operated by professional personnel in clinical settings. Operator uses interface to control light output, pulse frequency (1-500Hz), and treatment duration (1-30 min). Device emits energy to skin surface to treat acne, wrinkles, or provide thermal relief. Benefits include non-invasive treatment of skin conditions and temporary pain relief via tissue temperature elevation.

Clinical Evidence

Bench testing only. No clinical data included.

Technological Characteristics

Portable LED-based light therapy instrument. Wavelengths: Red (630±10nm), Blue (420±10nm), Yellow (590±10nm), Infrared (825±10nm). Adjustable irradiance (5 levels) and pulse repetition rates (1-500Hz). Components: stand, therapeutic head, color touch screen, power supply. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris, mild to moderate inflammatory acne, or periorbital wrinkles. Also indicated for patients requiring topical heating for relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, and to promote muscle relaxation and local blood circulation.

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

• Phototherapy Unit (K221083)
• LED Light Therapy Device Model: KN-7000C2 (K180900)

Submission Summary (Full Text)

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September 20, 2023

Shenzhenshi Sincoheren S&T Development Co.,Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K231894

Trade/Device Name: LED Spectrum therapy instrument 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: GEX, ILY Dated: June 28, 2023 Received: June 28, 2023

Dear Ray Wang:

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

Tanisha L. Hithe -S Tanisha L. 2023.09.20 Hithe -S 16:09:23 -04'00' Tanisha Hithe, MS, MHS 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

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# Indications for Use

510(k) Number (if known) K231894

#### Device Name

LED Spectrum therapy instrument (Model: PDT-I, PDT-J, PDT-K, PDT-L, PDT-M)

### Indications for Use (Describe)

The LED Spectrum therapy instrument includes five models, which are PDT-I, PDT-K, PDT-M.

# PDT-I:

Blue (420±10m) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Combination of Red (630±10mm) and Blue (420±10mm) is indicated for the treatment of mild to moderate inflammatory acne.

# PDT-J:

Combination of Yellow (590±10mm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

# PDT-K:

Blue (420±10mm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Combination of Red (630±10mm) is indicated for the treatment of mild to moderate inflammatory acne.

# PDT-L:

Combination of Red (630±10mm) and Infrared (825±10mm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

# PDT-M:

Combination of Yellow (590±10mm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: __ K231894

- 1. Date of Preparation: 09/01/2023
- 2. Sponsor

# Shenzhenshi Sincoheren S&T Development Co.,Ltd

Floor 4, No.2 Plant, No. 14 Zhongxing Road, Xiuxin Community, Kengzi Street Office, Pingshan District, Shenzhen City, China, 518118 Contact Person: Zhongzhou Li Position: General manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
# Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China, 102401 Contact Person: Ray Wang Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

#### 4. Proposed Device Identification

Trade Name: LED Spectrum therapy instrument Common Name: Powered Laser Surgical Instrument Model(s): PDT-I, PDT-J, PDT-K, PDT-L, PDT-M Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II

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### Product Code: GEX, ILY

Regulation Number: 21 CFR 878.4810 / 21 CFR 890.5500

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Review Panel: General & Plastic Surgery / Physical Medicine

#### Indication For Use Statement:

includes five models, which are PDT-I, PDT-J, PDT-K, The LED Spectrum therapy instrument PDT-L, PDT-M.

# PDT-I:

Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Combination of Red (630±10nm) and Blue (420±10mm) is indicated for the treatment of mild to moderate inflammatory acne.

#### PDT-J:

Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

### PDT-K:

Blue (420±10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Combination of Red (630±10nm) and Blue (420±10mm) is indicated for the treatment of mild to moderate inflammatory acne.

### PDT-L:

Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

#### PDT-M:

Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for

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the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

#### న్. Device Description

The LED Spectrum therapy instrument is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).

The device produces light in the following regions of the light spectrum:

- Red (630±10nm) .
- Blue (420±10nm) .
- . Yellow (590±10nm)
- . Infrared (825±10nm)

This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.

#### 6. Predicate Device Identification

# Primary Device:

510(k) Number: K221083 Product Name: Phototherapy Unit Manufacturer: MEDMIX Co., Ltd.

# Predicate Device:

510(k) Number: K180900 Product Name: LED Light Therapy Device Model: KN-7000C2 Manufacturer: Xuzhou Kernel Medical Equipment Co., Ltd.

#### 7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- A IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2: 2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- > IEC 60601-2-57: 2011 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for

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therapeutic diagnostic monitoring and cosmetic/aesthetic use

- > IEC 62471: 2006 Photobiological safety of lamps and lamp systems
- > ISO 14971: 2019 Medical devices - Application of risk management to medical devices
- 8. Clinical Test Conclusion

No clinical study is included in this submission.

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510(k) Summary

K231894

#### 9. Substantially Equivalent (SE) Comparison

Table 1 Comparison

| | | | Predicate Device | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------|
| ITEM | Proposed Device | Primary Device (K221083) | (K180900) | Remark |
| | | | Model: KN-7000C2 | |
| Product Code | GEX, ILY | GEX, ILY | OLP | Analysis 1 |
| Regulation No. | 21 CFR 878.4810 / 21 CFR 890.5500 | 21 CFR 878.4810 / 21 CFR 890.5500 | 21 CFR 878.4810 | SAME |
| Class | 2 | 2 | 2 | SAME |
| Indication for Use | The LED Spectrum therapy instrument<br>includes five models, which are PDT-I,<br>PDT-J, PDT-K, PDT-L, PDT-M.<br>PDT-I:<br>Blue (420±10nm) is generally indicated to treat dermatological conditions and<br>specifically indicated to treat moderate inflammatory acne vulgaris.<br>Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy<br>in the red and infrared region of the spectrum for use in dermatology for the treatment<br>of periorbital wrinkles.<br>Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatment<br>of mild to moderate inflammatory acne.<br>PDT-J:<br>Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emit<br>energy in the IR and visible spectrum to provide topical heating for the purpose of<br>elevating tissue temperature; for the temporary relief of minor muscle and joint pain,<br>arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle<br>tissue; and to temporarily increase local blood circulation where applied. | Blue (415-425nm), is generally indicated to treat<br>dermatological conditions and specifically indicated<br>to treat moderate inflammatory acne vulgaris.<br>Red (630-640nm) and Infrared (820-830nm)<br>Combination is intended to emit energy in the red and<br>infrared region of the spectrum for use in<br>dermatology for the treatment of periorbital wrinkles.<br>Combination of Infrared (820-830nm) and Yellow<br>(585-595nm) is intended to emit energy in the IR and<br>visible spectrum to provide topical heating for the<br>purpose of elevating tissue temperature; for the<br>temporary relief of minor muscle and joint pain,<br>arthritis and muscle spasm; relieving stiffness;<br>promoting the relaxation of muscle tissue; and to<br>temporarily increase local blood circulation where<br>applied. | The LED Light Therapy<br>Device is indicated for<br>the treatment of mild to<br>moderate inflammatory<br>acne. | SAME |
| | | | | |
| | Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy<br>in the red and infrared region of the spectrum for use in dermatology for the treatment<br>of periorbital wrinkles. | | | |
| | PDT-K: | | | |
| | Blue (420±10nm) is generally indicated to treat dermatological conditions and | | | |
| | specifically indicated to treat moderate inflammatory acne vulgaris. | | | |
| | Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatment | | | |
| | of mild to moderate inflammatory acne. | | | |
| | PDT-L: | | | |
| | Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energy | | | |
| | in the red and infrared region of the spectrum for use in dermatology for the treatment | | | |
| | of periorbital wrinkles. | | | |
| | PDT-M: | | | |
| | Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emit | | | |
| | energy in the IR and visible spectrum to provide topical heating for the purpose of | | | |
| | elevating tissue temperature; for the temporary relief of minor muscle and joint pain, | | | |
| | arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle | | | |
| | tissue; and to temporarily increase local blood circulation where applied. | | | |
| OTC or<br>Prescription Use | Prescription Use | Prescription Use | OTC | Difference<br>Analysis 2 |
| Configuration | Portable | Portable | Handheld | Difference<br>Analysis 3 |
| Components | Bracket, Therapeutic head, Operation panel, Power box | Stand, Head, Color touch screen, Power supplier | / | SAME |

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K231894

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510(k) Summary

K231894

| Wavelength | Red: 630±10nm | RED: 630-640nm | Red: 633±6nm | SAME |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Blue: 420±10nm | BLUE: 415-425nm | Blue: 415±5nm | |
| | Infrared: 825±10nm | IR: 820-830nm | | |
| | Yellow: 590±10nm | YELLOW: 585-595nm | | |
| Effective<br>irradiance | Adjustable 5 levels<br>Red: 20~45 mW/cm2<br>Blue: 10~40 mW/cm2<br>Infrared: 10~30 mW/cm2<br>Yellow: 10~18 mW/cm2<br>Combination of Red and Infrared: 30~75 mW/cm2<br>Combination of Red and Blue: 30~85mW/cm2<br>Combination of Yellow and Infrared: 20~48 mW/cm2 | Adjustable 5 levels<br>Red : 26-50 mW/cm2<br>Blue : 9~41 mW/cm2<br>IR: 11~28 mW/cm2<br>Yellow: 12-20mW/cm2<br>Combination of Red and Infrared: 37~78 mW/cm2<br>Combination of Yellow and Infrared: 23~48 mW/cm2 | Red light: 65±5 mW/cm2<br>Blue light: 35±5 mW/cm2<br>Combination of Red and<br>Blue: 110±10 mW/cm2 | Difference<br>Analysis 4 |
| Operation<br>interface | Continuous operation | Continuous operation | Continuous operation | SAME |
| Number of LEDs<br>in each panel | 156 | 288 | 8 | Difference<br>Analysis 5 |
| Pulse repetition<br>rate (Hz) | 1Hz, 5Hz, 10Hz, 50Hz, 100Hz, 150Hz, 200Hz and 500Hz | 1Hz, 5Hz, 10Hz, 50Hz, 100Hz, 150Hz, 200Hz and<br>500Hz | / | SAME |
| Max fluence<br>/energy density | Blue: 54 J/cm2 at 20 minutes treatment time<br>Combination of Red and Infrared: 90 J/cm2 at 20 minutes treatment time<br>Combination of Yellow and Infrared: 57.6 J/cm2 at 20 minutes treatment time | Blue: 49.2 J/cm2 at 20 minutes treatment time<br>Combination of Red and Infrared: 93.6 J/cm2 at 20<br>minutes treatment time<br>Combination of Yellow and Infrared: 57.6 J/cm2 at 20<br>minutes treatment time | / | Difference<br>Analysis 6 |
| | Combination of Red and Blue: 15.3 J/cm2 at 3 minutes treatment time | / | Combination of Red and<br>Blue: 13.2 J/cm2 at 2 | |
| | | minutes treatment time | | |
| Treatment time | 1-30 min adjustable<br>(Recommended 20 minutes for Single Blue Type, Combination of Red and Infrared<br>Type, Combination of Yellow and Infrared Type);<br>(Recommended 3 minutes for Combination of Red and Blue Type) | 20 min | Recommended for 2 min | Difference<br>Analysis 7 |
| Lamps working<br>distance | 7cm±2cm | 20cm | / | Difference<br>Analysis 8 |
| Standard | IEC 60601-1<br>IEC 60601-1-2…