(84 days)
The LED Spectrum therapy instrument includes five models, which are PDT-I, PDT-J, PDT-K, PDT-L, 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.
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.
The provided document is an FDA 510(k) Premarket Notification for a medical device called "LED Spectrum therapy instrument." It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and comparison of specifications.
Crucially, this document explicitly states: "No clinical study is included in this submission." (Page 7, Section 8)
Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study proving the device meets those criteria in the way requested by the prompt for the following reasons:
- No clinical trials: The submission did not include any clinical studies (human subject trials) to test the device's performance in achieving its intended medical outcomes (e.g., treating acne, reducing wrinkles).
- No acceptance criteria related to clinical performance: Since no clinical studies were performed for this submission, there are no acceptance criteria related to device performance in a clinical setting (e.g., accuracy, sensitivity, specificity, or improvement over human readers).
- No ground truth establishment for clinical performance: Without clinical data, there's no ground truth established to evaluate the device's efficacy for medical conditions.
The provided document details non-clinical tests (e.g., electrical safety, electromagnetic compatibility, photobiological safety, risk management) to ensure the device's safety and fundamental operation, and its equivalence to legally marketed predicate devices. The "acceptance criteria" discussed in the document are primarily related to compliance with these engineering and safety standards, as well as demonstrating comparable technical specifications (wavelengths, irradiance, etc.) to predicate devices.
However, to answer the prompt as best as possible, I will extrapolate what would typically be considered "acceptance criteria" and "proof" in this context, based on the information provided, recognizing that it pertains to non-clinical and comparative equivalence rather than direct clinical efficacy.
Based on the provided document, which focuses on substantial equivalence through non-clinical testing and comparison:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study was conducted in this submission, the "performance" here refers to meeting safety standards and having comparable technical specifications to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance (from "Non-Clinical Test Conclusion" and "Substantially Equivalent Comparison" sections) |
|---|---|
| Compliance with Electrical Safety Standards | Complies with IEC 60601-1: 2020 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) |
| Compliance with EMC Standards (Electromagnetic Disturbances) | Complies with 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) |
| Compliance with Non-Laser Light Source Equipment Standards | Complies with 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) |
| Compliance with Photobiological Safety Standards | Complies with IEC 62471: 2006 (Photobiological safety of lamps and lamp systems) |
| Compliance with Risk Management Standards | Complies with ISO 14971: 2019 (Medical devices - Application of risk management to medical devices) |
| Substantial Equivalence in Intended Use | The intended uses of the proposed device (treating moderate inflammatory acne vulgaris, periorbital wrinkles, mild to moderate inflammatory acne, temporary relief of minor muscle/joint pain, arthritis, muscle spasm, stiffness, promoting muscle relaxation, increasing local blood circulation) are found to be substantially equivalent to the predicate devices, despite some differences in specific combinations of wavelengths and models. The overall scope of indications is considered comparable or justified by the changes. |
| Substantial Equivalence in Light Wavelengths | Proposed Device: Red (630±10nm), Blue (420±10nm), Infrared (825±10nm), Yellow (590±10nm). Primary Predicate (K221083): Blue (415-425nm), Red (630-640nm), Infrared (820-830nm), Yellow (585-595nm). Predicate (K180900): Red (633±6nm), Blue (415±5nm). Considered "SAME" or "similar." |
| Substantial Equivalence in Effective Irradiance & Fluence/Energy Density | Proposed Device (ranges): Red: 20 |
| Configuration and Mechanical Performance | Portable, bracket/therapeutic head/operation panel/power box components. Differences from predicates in physical configuration (e.g., handheld vs. portable, number of LEDs, working distance) are addressed by stating compliance with IEC 60601-1 ensures mechanical performance and that the final light energy delivered (fluence/energy density) is the critical factor, which is deemed comparable. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable in the context of clinical human data. The "test set" here refers to the device prototypes themselves, not a dataset of patients.
- Data Provenance: Not applicable for clinical data. The non-clinical tests were presumably performed at the manufacturer's location (Shenzhen City, China) or accredited testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No ground truth in the sense of expert medical diagnosis or interpretation was established for a clinical test set, as no clinical study was performed. The "ground truth" for the non-clinical tests would be the specifications and requirements defined by the relevant international standards (e.g., IEC, ISO). Compliance with these standards is assessed through measurement and engineering verification, not human expert consensus on medical images or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As no clinical image or outcome data was evaluated by human experts, there was no need for an adjudication method.
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:
- No. The document explicitly states "No clinical study is included in this submission." Therefore, no MRMC study or AI-assisted human reader performance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a light therapy instrument, not an AI or algorithm. Its performance is measured by its physical light output parameters and safety, not by an algorithm's diagnostic or predictive capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the purposes of this 510(k) submission, the "ground truth" for the device's safety and performance claim (substantial equivalence) is compliance with international safety and performance standards (e.g., IEC 60601-1, IEC 60601-2-57, IEC 62471, ISO 14971) and comparison of technical specifications to legally marketed predicate devices. There is no clinical outcomes ground truth provided.
8. The sample size for the training set:
- Not applicable. This submission does not involve an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned in the document for an AI/ML model, this question does not apply.
In summary, the provided document is a 510(k) notification for a physical medical device (LED light therapy instrument) demonstrating substantial equivalence to predicates primarily through non-clinical engineering and safety testing, and comparative analysis of technical specifications. It does not involve AI, clinical trials, human reader studies, or the establishment of ground truth for clinical outcomes in the manner typically associated with the detailed questions of the prompt.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
{1}------------------------------------------------
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 (1-800-638-2041 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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
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 PRAStaff@fda.hhs.gov
"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."
{4}------------------------------------------------
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
-
- Date of Preparation: 09/01/2023
-
- 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: +86-15810585973 Fax: +86-755-84235904 Email: 1620096810@qq.com
-
- 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: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
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
{5}------------------------------------------------
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
{6}------------------------------------------------
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
{7}------------------------------------------------
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
-
- Clinical Test Conclusion
No clinical study is included in this submission.
{8}------------------------------------------------
510(k) Summary
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 instrumentincludes 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 andspecifically indicated to treat moderate inflammatory acne vulgaris.Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energyin the red and infrared region of the spectrum for use in dermatology for the treatmentof periorbital wrinkles.Combination of Red (630±10nm) and Blue (420±10nm) is indicated for the treatmentof mild to moderate inflammatory acne.PDT-J:Combination of Yellow (590±10nm) and Infrared (825±10nm) is intended to emitenergy in the IR and visible spectrum to provide topical heating for the purpose ofelevating tissue temperature; for the temporary relief of minor muscle and joint pain,arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscletissue; and to temporarily increase local blood circulation where applied. | Blue (415-425nm), is generally indicated to treatdermatological conditions and specifically indicatedto treat moderate inflammatory acne vulgaris.Red (630-640nm) and Infrared (820-830nm)Combination is intended to emit energy in the red andinfrared region of the spectrum for use indermatology for the treatment of periorbital wrinkles.Combination of Infrared (820-830nm) and Yellow(585-595nm) is intended to emit energy in the IR andvisible spectrum to provide topical heating for thepurpose of elevating tissue temperature; for thetemporary relief of minor muscle and joint pain,arthritis and muscle spasm; relieving stiffness;promoting the relaxation of muscle tissue; and totemporarily increase local blood circulation whereapplied. | The LED Light TherapyDevice is indicated forthe treatment of mild tomoderate inflammatoryacne. | SAME |
| Combination of Red (630±10nm) and Infrared (825±10nm) is intended to emit energyin the red and infrared region of the spectrum for use in dermatology for the treatmentof 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 orPrescription Use | Prescription Use | Prescription Use | OTC | DifferenceAnalysis 2 |
| Configuration | Portable | Portable | Handheld | DifferenceAnalysis 3 |
| Components | Bracket, Therapeutic head, Operation panel, Power box | Stand, Head, Color touch screen, Power supplier | / | SAME |
{9}------------------------------------------------
{10}------------------------------------------------
510(k) Summary
| 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 | |||
| Effectiveirradiance | Adjustable 5 levelsRed: 20 | Adjustable 5 levelsRed : 26-50 mW/cm2Blue : 9 | Red light: 65±5 mW/cm2Blue light: 35±5 mW/cm2Combination of Red andBlue: 110±10 mW/cm2 | DifferenceAnalysis 4 |
| Operationinterface | Continuous operation | Continuous operation | Continuous operation | SAME |
| Number of LEDsin each panel | 156 | 288 | 8 | DifferenceAnalysis 5 |
| Pulse repetitionrate (Hz) | 1Hz, 5Hz, 10Hz, 50Hz, 100Hz, 150Hz, 200Hz and 500Hz | 1Hz, 5Hz, 10Hz, 50Hz, 100Hz, 150Hz, 200Hz and500Hz | / | SAME |
| Max fluence/energy density | Blue: 54 J/cm2 at 20 minutes treatment timeCombination of Red and Infrared: 90 J/cm2 at 20 minutes treatment timeCombination of Yellow and Infrared: 57.6 J/cm2 at 20 minutes treatment time | Blue: 49.2 J/cm2 at 20 minutes treatment timeCombination of Red and Infrared: 93.6 J/cm2 at 20minutes treatment timeCombination of Yellow and Infrared: 57.6 J/cm2 at 20minutes treatment time | / | DifferenceAnalysis 6 |
| Combination of Red and Blue: 15.3 J/cm2 at 3 minutes treatment time | / | Combination of Red andBlue: 13.2 J/cm2 at 2 | ||
| minutes treatment time | ||||
| Treatment time | 1-30 min adjustable(Recommended 20 minutes for Single Blue Type, Combination of Red and InfraredType, Combination of Yellow and Infrared Type);(Recommended 3 minutes for Combination of Red and Blue Type) | 20 min | Recommended for 2 min | DifferenceAnalysis 7 |
| Lamps workingdistance | 7cm±2cm | 20cm | / | DifferenceAnalysis 8 |
| Standard | IEC 60601-1IEC 60601-1-2IEC 60601-2-57IEC 62471 | IEC 60601-1IEC 60601-1-2IEC 60601-2-57IEC 62471 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471ISO 10993-1ISO 10993-5ISO 10993-10 | DifferenceAnalysis 9 |
| Microprocessorcontrol | Yes | Yes | Yes | SAME |
| Continuous /Pulsed Output | Continuous and Pulsed | Continuous and Pulsed (up to 500 pulses per second) | Continuous and Pulsed | SAME |
{11}------------------------------------------------
{12}------------------------------------------------
Analysis 1/2:
The proposed device is different in Product Code from the predicate device (K180900). The intended use of the proposed device and predicate device (K180900) is the same, but the Type of Use is different. The predicate device is OTC device, the proposed device is Prescription Use device. Compared with OTC, the risk of Prescription Use is lower, so we believe that this difference will not raise any risks, both the proposed device and predicate device (K180900) are safe and effective.
Analysis 3:
The proposed device is different in Configuration from the predicate device (K180900). However, the configuration difference are just in physical specification and this difference will not raise any issues in safety and effectiveness. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Analysis 4:
The proposed device has similar Effective irradiance with the primary predicate device (K221083) in Red, Blue, Infrared, Yellow light source and also similar in Combination of Red and Infrared type and Combination of Yellow and Infrared type.
For the Combination of Red and Blue type, the proposed device is different with the secondary predicate device (K180900). From the comparison above, we can see the proposed devices' effective irradiance is less than secondary predicate's, so it means the proposed device will not raise safety concerns in this particular difference. (Because the main risk of light irradiation therapy is the heat energy converted by light irradiation. The greater the light irradiation, the higher the temperature of the treatment site, and the greater the risk of the patient being burned). But smaller effective irradiance may raise the effectiveness concerns, the proposed device may not achieve it's claimed indication for use. Considering that the final energy acting on the human body is the fluence/energy density (J/cm²), and the fluence/energy density (J/cm2) is the effective irradiance (mW/cm²) multiplied by the treatment time, that is, the actual energy acting on the human body is the accumulation of effective irradiance (mW/cm²) energy in the human body. Therefore, when considering the difference in effective irradiance (mW/cm²), we should take the fluence/energy density (J/cm²) acting on the human body. We also conducted comparison about fluence/energy density (J/cm²) in table above and provided the difference in Analysis 6 below, according to the results of difference analysis 6 below, the proposed device has similar fluence/energy density (J/cm²) with both primary and secondary predicate device. Therefore, this difference will not affect safety and effectiveness of the proposed device
Analysis 5:
The proposed device is different in Number of LEDs in each panel from the primary device (K221083) and predicate device (K180900). However, the therapeutic effect and harm of the final light energy are determined by the light energy acting on human body, which are fluence/energy
{13}------------------------------------------------
density (J/cm²).
So, no matter the number of light sources will not affect and risk of the final treatment. Additionally, by complying with IEC 60601-1, the mechanical and heat performance of the proposed device is determined to be accepted.
Therefore, this difference will not affect safety and effectiveness of the proposed device.
Analysis 6:
The Max fluence /energy density is calculated based on the treatment time. The Max fluence /energy density is equal to the effective irradiance by the treatment time. The final energy density can be adjusted by recommending treatment times. From the comparison above, the proposed device has similar fluence/energy density (J/cm²) with primary predicate device (K221083) at 20 minutes treatment time, and also has similar fluence/energy density (J/cm2) with secondary predicate device at 3 minutes treatment time. And the minor differences are all within ± 20% acceptable range.
Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Analysis 7:
The proposed device is different in Treatment time from the primary devices. Although our treatment time is adjustable from 1-30 minutes, but we recommend a treatment time of 20 minutes and 3 minutes for different output energy type (we have added this information in Chapter 1.5 of the manual).
Additionally, the standard of IEC 60601-2-57 classified continuous running LS equipment, and the test results showed that even under the maximum energy flux of 30 minutes, we still comply with IEC 60601-2-57 and IEC 60601-1.
Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Analysis 8:
The proposed device is different in Lamps working distance from the predicate device.
The Effective radiation refers to the effective light energy intensity on the irradiated surface (the skin surface), and the effective radiation of the proposed device is measured at a distance of 7cm from the light source.
Although the Lamps working distance of the proposed device is different from that of the predicate device, the effective radiation received by the two on the unit area of the irradiation surface is same (skin surface).
Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Analysis 9:
The proposed device is different in Standard from the predicate device (K180900). The proposed device is Prescription Use and operated by professional personnel, so it does not need to be tested by IEC 60601-1-11. Moreover, the proposed device does not contact with patients, so it does not
{14}------------------------------------------------
need to be tested according to ISO 10993-1. Therefore, this difference will not affect safety and effectiveness of the proposed device.
10. Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device (K221083 and K180900).
§ 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.