Photodynamic Therapy (PDT) Equipment

K200751 · Shangdong Huamei Technology Co., Ltd. · GEX · May 21, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200751
• Device Name: Photodynamic Therapy (PDT) Equipment
• Applicant: Shangdong Huamei Technology Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (630mm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions. The infrared light (835nm wavelength) is generally use 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

HM-PDT 900 is a vertical LED-based phototherapy device for dermatological and musculoskeletal conditions. It utilizes five LED panels to emit red (630nm), blue (415nm), and infrared (835nm) light. Operated by clinicians in a clinical setting, the device delivers specific energy densities to the skin surface. The device is used to manage acne, vascular/pigmented lesions, and provide temporary pain relief/increased circulation. Clinical decision-making is guided by the selection of light wavelength based on the patient's condition. The device benefits patients by providing non-invasive therapeutic light energy for aesthetic and pain management purposes.

Clinical Evidence

No clinical data. Bench testing only, including energy density output accuracy, wavelength accuracy, and software verification/validation.

Technological Characteristics

Vertical LED-based phototherapy device. Emits red (630±15nm), blue (415±15nm), and infrared (835±15nm) light. Features 5 LED panels with 300 total LEDs. Power supply: AC 100-240V. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471. Connectivity: Standalone.

Indications for Use

Indicated for patients with moderate inflammatory acne vulgaris (blue light), superficial benign vascular and pigmented lesions (red light), and patients requiring temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, or increased local blood circulation (infrared 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

• Phototherapy System (K190938)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Shangdong Huamei Technology 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: K200751

Trade/Device Name: Photodynamic Therapy (PDT) Equipment 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 Dated: March 20, 2020 Received: March 23, 2020

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 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

{1}------------------------------------------------

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,

Colin Kejing Chen Acting 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K200751

### Device Name

Photodynamic Therapy (PDT) Equipment

### Indications for Use (Describe)

The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The red light (630mm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions.

The infrared light (835nm wavelength) is generally use 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K200751

# K200751 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 Title 21, CFR Section 807.92.

The assigned 510(k) Number: K200751

- 1. Date of Preparation: 05/18/2020
- 2. Sponsor Identification

### Shangdong Huamei Technology Co., Ltd.

No. 588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261205

Contact Person: Xu QingHua Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Mr. Ray Wang

## Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: [phone] Fax: [phone] Email: ray.wang(@believe-med.com

{4}------------------------------------------------

#### 4. Identification of Proposed Device

Trade Name: Photodynamic Therapy (PDT) Equipment Common Name: Powered Laser Surgical Instrument Model(s): HM-PDT 900

Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;

Indication For Use Statement:

The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The red light (630mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.

The infrared light (835nm wavelength) is generally use 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 Description:

The Photodynamic Therapy (PDT) Equipment HM-PDT 900 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (630±15nm), in the blue light regions of the light spectrum (415±15nm) and infrared light region of light spectrum (835±15nm). Five sets of LEDs panels are available for the device.

- 5. Identification of Predicate Device(s)
### K190938

Phototherapy System Shanghai Apolo Medical Technology Co., Ltd.

#### 6. 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:

{5}------------------------------------------------

- a) IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
b) IEC 60601-1:2005/A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

c) IEC60601-2-57:2011, Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

d) IEC 62471:2006 Photobiological safety of lamps and lamp systems.

- e) Software Verification and Validation Testing
- f) Bench Testing (Energy density output accuracy, Wavelength accuracy)
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

{6}------------------------------------------------

#### Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device | Predicate Device<br>(K190938) | Remark |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Product Code | GEX | GEX | SAME |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | II | II | SAME |
| Intended Use | The Photodynamic Therapy (PDT)<br>Equipment use of the red, blue and<br>infrared regions of the spectrum is<br>intended to emit energy to treat<br>dermatological conditions. | Phototherapy Systems use of the<br>red, blue and infrared regions of<br>the spectrum is intended to emit<br>energy to treat<br>dermatological conditions. | SAME |
| | The blue light (415nm wavelength)<br>is generally indicated to treat<br>dermatological conditions and<br>specifically indicated to treat<br>moderate inflammatory acne<br>vulgaris. | The blue light (415nm<br>wavelength) is generally indicated<br>to treat dermatological conditions<br>and specifically indicated to treat<br>moderate inflammatory acne<br>vulgaris | |
| | The red light (630nm wavelength)<br>is generally indicated to treatment<br>of superficial, benign vascular, and<br>pigmented lesions. | The red light (630nm wavelength)<br>is generally indicated to treatment<br>of superficial, benign vascular, and<br>pigmented lesions | |
| | The infrared light (835nm<br>wavelength) is generally use for the<br>temporary relief of minor muscle<br>and joint pain, arthritis and muscle<br>spasm; relieving stiffness;<br>promoting the relaxation of muscle<br>tissue; and to temporarily increase<br>local blood circulation where<br>applied. | The infrared light (835nm<br>wavelength) is generally use for<br>the temporary relief of minor<br>muscle and joint pain, arthritis<br>and muscle spasm; relieving<br>stiffness; promoting the relaxation<br>of muscle tissue; and to<br>temporarily increase local blood<br>circulation where applied. | |
| ITEM | Proposed Device | Predicate Device<br>(K190938) | Remark |
| Wavelength<br>(nm) | Red light 630nm±15nm<br>Blue light 415nm±15nm<br>Infrared light 835nm±15nm | Red light 630±15nm;<br>Blue light 415±5nm;<br>NIR light 835±10nm | SAME |
| Panels Type | 5panel: 300 EALEDs.<br>The panels may emit the three<br>light (red, blue, infrared) | 3panel: 180EA LEDS<br>4 Panel: 240 EALEDs.<br>The panels may emit the three<br>light (red, blue, infrared) | Analysis |
| Light frequency | 200Hz | 200Hz | SAME |
| LED power | Each LED lamp bead has 3 diodes<br>that emit different colors, the<br>Energy power of a diode is 3W. | Each LED lamp bead has 3 diodes<br>that emit different colors, the<br>Energy power of a diode is 3W. | SAME |
| Maximum<br>power<br>density in mW<br>(J) | (1) Red light: 115mW/cm2<br>(242J/cm2),<br>(2) Blue light:<br>120mW/cm2(180J/cm2),<br>(3) IR: 70mW/cm2(147J/cm2) | (1) Red light: 115mW/cm2<br>(242J/cm2),<br>(2) Blue light:<br>120mW/cm2(180J/cm2),<br>(3) IR: 70mW/cm2(147J/cm2) | SAME |
| Treatment area | 1410cm2 | 756cm2 and 1008cm2 | Analysis |
| Treatment time | 20 minutes (recommended<br>Treatment Time) | 20 minutes (recommended<br>Treatment Time) | SAME |
| Numbers of<br>LEDs | 5 panels:300EA | 3 panels: 180EA,<br>4 panels: 240EA. | Analysis |
| Working<br>distance | 10~15cm | 10~15cm | SAME |
| Power supply | AC 100-240V 50/60Hz 500VA | AC 100-240V 50/60Hz 10A | SAME |
| Dimension | 638mm×243mm×1560mm (Host)<br>494mm×346mm×69 (LEDs<br>Panels ) | 500mm[H]× 500[W]× 1350[D] | Analysis |
| Electrical<br>Safety | Comply with IEC 60601-1 and IEC<br>60601-1-2 | Comply with IEC 60601-1 and<br>IEC 60601-1-2 | SAME |
| Radiation<br>Safety | Comply with IEC 60601-2-57 | Comply with IEC 60601-2-57 | SAME |
| Photobiological<br>safety | Comply with IEC 62471 | Comply with IEC 62471 | SAME |

# Table 7-1 General Comparison

{7}------------------------------------------------

| | Table 7-2 Performance Comparison | |
|--|----------------------------------|--|
| | | |

## Analysis:

The proposed device has different panel number, diode number of each LED, LED number, and treatment area than predicate device, but the difference does not affect the output energy for treatment. Therefore, the slight difference is considered to have no effectiveness and safe.

{8}------------------------------------------------

- 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.