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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for a Photodynamic Therapy (PDT) Equipment. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, clinical study specifics, and expert involvement is not available in this document.

Here's a breakdown of the information that can be extracted and what is explicitly stated as not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with numerical performance goals and achieved results for clinical effectiveness. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and safety standards.

The "performance comparison" in Table 7-2 highlights similarities and differences between the proposed device and the predicate. The "acceptance criteria" here is effectively "substantially equivalent to the predicate device."

Feature/Parameter	Acceptance Criteria (Substantially Equivalent to Predicate K190938)	Reported Device Performance (Proposed Device)	Remark
Product Code	GEX	GEX	SAME
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	SAME
Class	II	II	SAME
Intended Use	Same as Predicate	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.	SAME
Blue Light (415nm) Indication	Treat dermatological conditions and specifically moderate inflammatory acne vulgaris.	Treat dermatological conditions and specifically moderate inflammatory acne vulgaris.	SAME
Red Light (630nm) Indication	Treatment of superficial, benign vascular, and pigmented lesions.	Treatment of superficial, benign vascular, and pigmented lesions.	SAME
Infrared Light (835nm) Indication	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.	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.	SAME
Wavelength (nm)	Red light 630±15nm; Blue light 415±5nm; NIR light 835±10nm	Red light 630nm±15nm; Blue light 415nm±15nm; Infrared light 835nm±15nm	SAME (Note: Blue light wavelength tolerance slightly different for predicate, but declared "SAME")
Light frequency	200Hz	200Hz	SAME
LED power (per diode)	3W	3W	SAME
Max Power Density (Red)	115mW/cm2 (242J/cm2)	115mW/cm2 (242J/cm2)	SAME
Max Power Density (Blue)	120mW/cm2 (180J/cm2)	120mW/cm2 (180J/cm2)	SAME
Max Power Density (IR)	70mW/cm2 (147J/cm2)	70mW/cm2 (147J/cm2)	SAME
Treatment time	20 minutes (recommended)	20 minutes (recommended)	SAME
Working distance	10~15cm	10~15cm	SAME
Power supply	AC 100-240V 50/60Hz 10A	AC 100-240V 50/60Hz 500VA (Note: 10A vs 500VA; implies similar power draw)	SAME
Electrical Safety	Comply with IEC 60601-1 and IEC 60601-1-2	Comply with IEC 60601-1 and IEC 60601-1-2	SAME
Radiation Safety	Comply with IEC 60601-2-57	Comply with IEC 60601-2-57	SAME
Photobiological safety	Comply with IEC 62471	Comply with IEC 62471	SAME
Panels Type	3panel: 180EA LEDS; 4 Panel: 240 EALEDs. Panels may emit three lights (red, blue, infrared).	5panel: 300 EALEDs. Panels may emit the three light (red, blue, infrared).	Analysis (Differences in panel/LED count, but deemed not to affect output energy)
Treatment area	756cm2 and 1008cm2	1410cm2	Analysis (Difference, but deemed not to affect output energy)
Numbers of LEDs	3 panels: 180EA; 4 panels: 240EA.	5 panels: 300EA.	Analysis (Difference, but deemed not to affect output energy)
Dimension	500mm[H]× 500[W]× 1350[D]	638mm×243mm×1560mm (Host); 494mm×346mm×69 (LEDs Panels)	Analysis (Difference, but deemed not to affect output energy)

Analysis from document regarding "differences": "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."

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. No clinical test set.
Data Provenance: Not applicable. The submission relies on non-clinical bench testing and adherence to international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set or ground truth derived from expert consensus for clinical performance. The "ground truth" for non-clinical tests would be the established specifications and standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set.

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 light therapy equipment, not an AI diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device. The device's performance is measured by its output parameters (wavelength, power density, etc.) as confirmed by bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests (bench testing): The "ground truth" would be the engineering specifications and established performance limits defined by international standards (e.g., IEC 60601 series, IEC 62471).

8. The sample size for the training set:

Not applicable. No training set was used as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary from the document regarding studies:

Clinical Test Conclusion: "No clinical study is included in this submission." (Page 5)
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:
- IEC 60601-1-2:2014 (EMC)
- IEC 60601-1:2005/A1:2012 (Basic safety and essential performance)
- IEC 60601-2-57:2011 (Non-laser light source equipment safety)
- IEC 62471:2006 (Photobiological safety)
- Software Verification and Validation Testing
- Bench Testing (Energy density output accuracy, Wavelength accuracy)" (Page 5-6)

In essence, the acceptance criteria for this device's 510(k) clearance was its ability to demonstrate substantial equivalence to a previously cleared predicate device through non-clinical testing verifying its physical and electrical performance parameters, and by adhering to relevant safety and performance standards. No clinical efficacy or performance studies with human subjects were conducted or required for this submission.

Summary

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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

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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 (1-800-638-2041 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

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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.

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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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
1. 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: +86-536-2110001 Fax: +86-536-2109823 Email: xuqh@yeah.net

1. 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: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang(@believe-med.com

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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.

Device Description:

1. 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:

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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)
1. Clinical Test Conclusion

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed Device	Predicate Device(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)Equipment use of the red, blue andinfrared regions of the spectrum isintended to emit energy to treatdermatological conditions.	Phototherapy Systems use of thered, blue and infrared regions ofthe spectrum is intended to emitenergy to treatdermatological conditions.	SAME
	The blue light (415nm wavelength)is generally indicated to treatdermatological conditions andspecifically indicated to treatmoderate inflammatory acnevulgaris.	The blue light (415nmwavelength) is generally indicatedto treat dermatological conditionsand specifically indicated to treatmoderate inflammatory acnevulgaris
	The red light (630nm wavelength)is generally indicated to treatmentof superficial, benign vascular, andpigmented lesions.	The red light (630nm wavelength)is generally indicated to treatmentof superficial, benign vascular, andpigmented lesions
	The infrared light (835nmwavelength) is generally use for thetemporary relief of minor muscleand joint pain, arthritis and musclespasm; relieving stiffness;promoting the relaxation of muscletissue; and to temporarily increaselocal blood circulation whereapplied.	The infrared light (835nmwavelength) is generally use forthe temporary relief of minormuscle and joint pain, arthritisand muscle spasm; relievingstiffness; promoting the relaxationof muscle tissue; and totemporarily increase local bloodcirculation where applied.
ITEM	Proposed Device	Predicate Device(K190938)	Remark
Wavelength(nm)	Red light 630nm±15nmBlue light 415nm±15nmInfrared light 835nm±15nm	Red light 630±15nm;Blue light 415±5nm;NIR light 835±10nm	SAME
Panels Type	5panel: 300 EALEDs.The panels may emit the threelight (red, blue, infrared)	3panel: 180EA LEDS4 Panel: 240 EALEDs.The panels may emit the threelight (red, blue, infrared)	Analysis
Light frequency	200Hz	200Hz	SAME
LED power	Each LED lamp bead has 3 diodesthat emit different colors, theEnergy power of a diode is 3W.	Each LED lamp bead has 3 diodesthat emit different colors, theEnergy power of a diode is 3W.	SAME
Maximumpowerdensity in mW(J)	(1) Red light: 115mW/cm2(242J/cm2),(2) Blue light:120mW/cm2(180J/cm2),(3) IR: 70mW/cm2(147J/cm2)	(1) Red light: 115mW/cm2(242J/cm2),(2) Blue light:120mW/cm2(180J/cm2),(3) IR: 70mW/cm2(147J/cm2)	SAME
Treatment area	1410cm2	756cm2 and 1008cm2	Analysis
Treatment time	20 minutes (recommendedTreatment Time)	20 minutes (recommendedTreatment Time)	SAME
Numbers ofLEDs	5 panels:300EA	3 panels: 180EA,4 panels: 240EA.	Analysis
Workingdistance	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)494mm×346mm×69 (LEDsPanels )	500mm[H]× 500[W]× 1350[D]	Analysis
ElectricalSafety	Comply with IEC 60601-1 and IEC60601-1-2	Comply with IEC 60601-1 andIEC 60601-1-2	SAME
RadiationSafety	Comply with IEC 60601-2-57	Comply with IEC 60601-2-57	SAME
Photobiologicalsafety	Comply with IEC 62471	Comply with IEC 62471	SAME

Table 7-1 General Comparison

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	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.

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1. 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.

Regulation Number and Section

§ 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.