(59 days)
Not Found
No
The summary describes a light therapy device with specific wavelengths and LED panels. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on electrical safety, photobiological safety, and basic device performance metrics like energy density and wavelength accuracy.
Yes
The device is intended to treat specific medical conditions, such as dermatological conditions, acne vulgaris, vascular and pigmented lesions, and muscle/joint pain, which are therapeutic uses.
No
The intended use and indications for use describe the device as emitting energy to treat conditions, not to diagnose them.
No
The device description explicitly states it is a "vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes)" and mentions "Five sets of LEDs panels are available for the device." This indicates the device includes significant hardware components (LEDs, panels, vertical structure) beyond just software. The performance studies also include hardware-related tests like "Energy density output accuracy" and "Wavelength accuracy."
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The provided description clearly states that this device is a Photodynamic Therapy (PDT) Equipment that uses light to treat dermatological conditions, pain, and other physical ailments. It emits energy directly onto the body.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens (blood, tissue, etc.) outside of the body.
The device is a therapeutic device that applies light energy directly to the patient's body for treatment purposes, which is the opposite of how an IVD functions.
N/A
Intended Use / Indications for 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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
No clinical study is included in this submission.
Description of the test set, sample size, data source, and annotation protocol
No clinical study is included in this submission.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 60601-1-2:2014, 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Pre-determined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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 (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.
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)
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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
-
- Date of Preparation: 05/18/2020
-
- 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
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
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.
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.
-
- 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)
-
- 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 and
infrared regions of the spectrum is
intended to emit energy to treat
dermatological conditions. | Phototherapy Systems use of the
red, blue and infrared regions of
the spectrum is intended to emit
energy to treat
dermatological conditions. | SAME |
| | The blue light (415nm wavelength)
is generally indicated to treat
dermatological conditions and
specifically indicated to treat
moderate inflammatory acne
vulgaris. | The blue light (415nm
wavelength) is generally indicated
to treat dermatological conditions
and specifically indicated to treat
moderate inflammatory acne
vulgaris | |
| | The red light (630nm wavelength)
is generally indicated to treatment
of superficial, benign vascular, and
pigmented lesions. | The red light (630nm 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. | 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. | |
| ITEM | Proposed Device | Predicate Device
(K190938) | Remark |
| Wavelength
(nm) | Red light 630nm±15nm
Blue light 415nm±15nm
Infrared 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 three
light (red, blue, infrared) | 3panel: 180EA LEDS
4 Panel: 240 EALEDs.
The panels may emit the three
light (red, blue, infrared) | Analysis |
| Light frequency | 200Hz | 200Hz | SAME |
| LED power | Each LED lamp bead has 3 diodes
that emit different colors, the
Energy power of a diode is 3W. | Each LED lamp bead has 3 diodes
that emit different colors, the
Energy power of a diode is 3W. | SAME |
| Maximum
power
density 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 (recommended
Treatment Time) | 20 minutes (recommended
Treatment Time) | SAME |
| Numbers of
LEDs | 5 panels:300EA | 3 panels: 180EA,
4 panels: 240EA. | Analysis |
| Working
distance | 1015cm | 1015cm | SAME |
| Power supply | AC 100-240V 50/60Hz 500VA | AC 100-240V 50/60Hz 10A | SAME |
| Dimension | 638mm×243mm×1560mm (Host)
494mm×346mm×69 (LEDs
Panels ) | 500mm[H]× 500[W]× 1350[D] | Analysis |
| 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 |
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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-
- 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.
- Substantially Equivalent (SE) Conclusion