(77 days)
Phototherapy Systems 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, atthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Phototherapy Systems HS-770 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). Three or four sets of LEDs panels are available for the device.
The provided text is a 510(k) Summary for a Phototherapy System, which details its specifications and compares it to a predicate device. It explicitly states that clinical testing was not applicable or performed for this submission to establish substantial equivalence.
Therefore, the document does not contain any information regarding acceptance criteria studies, device performance metrics against such criteria, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or details about training sets.
The information provided only covers non-clinical testing for electrical safety and electromagnetic compatibility to demonstrate compliance with recognized standards.
Based on the provided text, I cannot answer the questions about acceptance criteria and the study that proves the device meets them because the document states "Clinical Testing: It is not applicable."
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Shanghai Apolo Medical Technology Co., Ltd. % Felix Li Regulatory Affairs 4F, Building A No. 388 Yindu Road Xuhui District Shanghai, 200231 China
June 26, 2019
Re: K190938
Trade/Device Name: Phototherapy System 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: April 4, 2019 Received: April 10, 2019
Dear Felix Li:
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 mediation-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.
Neil R.P. Ogden, MS Acting Assistant Director, THT4A3: Light Based Devices Team 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190938
Device Name Phototherapy Systems
Indications for Use (Describe)
Phototherapy Systems 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, atthritis 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)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I Submitter
Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231,China
Establishment Registration Number: 3007120647
Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn
II Proposed Device
| Trade Name of Device: | Phototherapy Systems |
|---|---|
| Common name: | Powered Laser Surgical Instrument |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product code: | GEX |
| Review Panel: | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K120460 |
|---|---|
| Trade name: | SMARTLUX |
| Common name: | Visible and Infrared Light Source |
| Classification: | Class II |
| Product Code: | GEX |
| Manufacturer | Medmix Co, Ltd. |
IV Device description
The Phototherapy Systems HS-770 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). Three or four sets of LEDs panels are available for the device.
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V Indication for use
Phototherapy Systems 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 (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.
| Item | Subject device | Predicate device(K120460) |
|---|---|---|
| Product name | Phototherapy System(HS-770) | SMARTLUX |
| Product Code | GEX | GEX |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | Class II | Class II |
| Indication for use | Phototherapy Systems use of thered, blue and infrared regions ofthe spectrum is intended to emitenergy to treat dermatologicalconditions.The blue light (415nm wavelength)is generally indicated to treatdermatological conditions andspecifically indicated to treatmoderate inflammatory acnevulgarisThe red light (630nm wavelength)is generally indicated to treatmentof superficial, benign vascular, andpigmented lesions | 633nm wave length:Dermatology for treatments ofsuperficial, benign vascular,and pigmented lesion415nm wave length:dermatological condition andspecifically indicated totreatment moderateinflammatory acne vulgaris830nm wave length:temporary relief of minormuscle and joint pain, arthritisand muscle spasm; relievingstiffness; promoting therelaxation of muscle tissue;and to temporarily increaselocal blood circulation where |
| 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. | applied. | |
| Power supply wavelength | AC 100-240V 50/60Hz 10ARed light 630nm ± 15nmBlue light 415nm ± 15nmInfrared light 835nm ± 15nm | AC 100-240V 47-63HzRed light 633nm ± 6nmBlue light 415nm ± 5nmInfrared light 830nm ± 5nm |
| Panels Type | 3 panel: 180EA LEDs 4 Panel: 240 EA LEDs. The panels may emit the three light (red, blue, infrared) individual or in combination | Four type, each head type has only one light. Red Blue Infrared Red+Infrared |
| Light frequency | 200Hz | unknown |
| Output Power | Each LED lamp bead has 4 diodes that emit different colors, the energy power of a diode is 3W. | unknown |
| Maximum power density in mW | (1) Red light: 115mW/cm²,(2) Blue light: 120mW/cm²,(3) IR: 70mW/cm²,(4) Red/IR: 120mW/cm²(5) Blue/IR: 150mW/cm² | (1) Red: 115mW/cm²(2) Blue: 75mW/cm²(3) IR 60W/cm²(4) Red/IR: 75mW/cm² |
| Standard does in Joules | (1) Red light: 138J/cm²,(2) blue light: 144J/cm²,(3) IR: 84J/cm²,(4) Red/IR: 144J/cm²(5) Blue/IR: 180J/cm² | (1) Red: 138J/cm²(2) Blue: 90J/cm²(3) Infrared: 72J/cm²(4) Red/IR: 90J/cm² |
| Adjustable dose range | (1) Red light: 1-242J/cm²,(2) blue light: 1-180J/cm²,(3) IR: 1-147J/cm²,(4) Red/IR: 1-144J/cm² | (1) Red light: 1-276J/cm²,(2) blue light: 1-180J/cm²,(3) IR: 1-144J/cm²,(4) Red/IR: 1-180J/cm² |
VI Comparison of technological characteristics with the predicate devices
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| Treatment area | $756cm^2$ and $1008cm^2$ | $779cm^2$ |
|---|---|---|
| Treatment time | 20minutes (recommended Treatment Time) | 20minutes(recommended standard dose) |
| Numbers of LEDs | 3 panels: 180EA,4 panels: 240EA. | Red: 2400EA,Blue: 1500EAInfrared:800EARed+IR:Red: 700EAIR: 500EA |
| Working distance | 10~15cm | |
| Operation interface | Display Screen | Display Screen |
| Dimension | 500mm[H]× 500[W]× 1350[D] | 390mm[H]×540mm[W]×840 mm[D] |
| Safety classification | Class I | Class I |
| Software | Yes | Yes |
VII Non-Clinical Testing
A battery of tests to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility
IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 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 therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
VIII Clinical Testing
It is not applicable.
IX Conclusion
Base on the performance testing and validation studies that the subject device is substantially equivalent to the predicate device.
§ 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.