(77 days)
Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±8nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (830±8mm 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 photon therapy apparatus (BL-10) use 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 (633±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm).
The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources.
The provided document is a 510(k) summary for the Xemis Medical Technology (Shenzhen) Co., Ltd. "Photon Therapy Apparatus (BL-10)". It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
However, the document does not contain specific acceptance criteria and detailed study results as would be typically found for a study proving a device meets acceptance criteria, especially in the context of an AI/ML-driven device's performance. The provided text primarily focuses on the device's technical specifications and a comparison to predicate devices, stating that "Non-clinical tests" were performed for electrical safety, EMC, performance, and software verification/validation. It explicitly states "Clinical study: Not applicable."
Therefore, based on the provided text, I cannot fulfill most of your requested information as it pertains to clinical performance studies, acceptance criteria, test set details (sample size, data provenance, ground truth experts, adjudication), MRMC studies, or standalone algorithm performance, and training set details for an AI/ML device.
The document describes a photon therapy apparatus, which is a physical device emitting light for dermatological conditions, not an AI/ML-driven medical device that would involve a test set, ground truth interpretation by experts, or MRMC studies.
If this was a request for information on an AI/ML device, the provided text would be a "reject" or "missing information" response. As it is not an AI/ML device, the traditional performance acceptance criteria for a medical device of this type would typically involve measurements of parameters like wavelength, power output, irradiance, and safety adherence to relevant electrical and photobiological safety standards, which are mentioned generally.
Here's what I can extract from the document regarding "acceptance criteria" in a general sense, and "study" information as provided:
1. Table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of acceptance criteria with corresponding performance results in a standalone "acceptance criteria" section. Instead, the basis for "acceptance" (or rather, substantial equivalence for FDA clearance) is demonstrated through comparison of the proposed device's specifications and performance to predicate devices. The "performance" here refers to meeting technical specifications and safety standards, rather than clinical efficacy outcome measures from a trial.
| Feature/Criterion (Implied Acceptance) | Proposed Device Performance (BL-10) | Basis for "Acceptance" (Substantial Equivalence) |
|---|---|---|
| Wavelengths | Red light: 633±8nm, Blue light: 417±8nm, Yellow light: 590±8nm, Infrared: 830±8nm | Comparable to predicate devices (e.g., Red: 633±10nm, Blue: 417±10nm, Yellow: 590±10nm, Infrared: 835±15nm for K222751). |
| Maximum Power Density (mW/cm²) | Red: 80mW/cm², Blue: 100mW/cm², Yellow: 35W/cm² (note discrepancy in unit for Yellow vs. others), Infrared: 50mW/cm² | Comparable to predicate devices (e.g., K222751: Red 20 |
| Standard Doses (Joules) | Red: 96J/cm², Blue: 120J/cm², Yellow: 42J/cm², Infrared: 60J/cm² | Comparable to predicate devices (e.g., K222751: Red 155J/cm², Blue 144J/cm², Yellow 42J/cm², IR 84J/cm²; K190938: Red 138J/cm², Blue 144J/cm², IR 84J/cm²; K200104: Red 120J/cm², Blue 54J/cm², Yellow 42J/cm²). |
| Adjustable Dose Range | Red: 1-144J/cm², Blue: 1-180J/cm², Yellow: 1-63J/cm², Infrared: 3-90J/cm² | Comparable to predicate devices' adjustable ranges. |
| Effective Irradiation Area (CM²) | 825cm² and 1375cm² | Comparable to predicate devices (e.g., K222751: 900cm² ±10%; K190938: 756cm² and 1008cm²; K200104: 500cm² and 860cm²). |
| Safety and Performance Standards | Passed tests according to: ANSI AAMI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471. | Adherence to recognized national and international safety standards is an acceptance criterion for medical devices. |
| Software Verification & Validation | System verification testing presented in this 510(k) demonstrated that all software requirement specifications are met. (Basic Documentation Level of concern). | Software functionality and safety are confirmed. |
| Intended Use | Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions (with specific indications for each light color). | "The indications for use of the Photon Therapy Apparatus are the same as those for the predicate devices." (Page 10) |
| Technological Differences | None identified that "raise new or different questions of safety or effectiveness." (Page 10) | This is a key criterion for substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document describes a physical medical device (photon therapy apparatus), not an AI/ML diagnostic or prognostic algorithm that would have a "test set" of patient data. The "tests" mentioned are non-clinical (electrical safety, EMC, performance, software V&V).
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. As above, no clinical "test set" and thus no ground truth established by experts is described for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical "test set" and thus no adjudication method is mentioned.
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 is not an AI-assisted diagnostic device, so no MRMC study was performed. The document explicitly states "Clinical study: Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's performance would be the physical measurements of its light output and adherence to electrical safety standards, not clinical ground truth from patient data.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
In summary, the provided document is a 510(k) notification for a photon therapy device, focusing on demonstrating substantial equivalence to predicate devices based on technical specifications and non-clinical safety/performance testing. It does not involve AI/ML components or clinical performance studies typically associated with the detailed criteria you've outlined.
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Xemis Medical Technology (Shenzhen) Co., Ltd. Yongfen Yang RA Engineer 1101/1102/1201/1202, Unit 1, Building 2, Hongpeng Building, Tiegang Community, Xixiang Street, Baoan Shenzhen, Guangdong 518102 China
Re: K243993
Trade/Device Name: Photon Therapy Apparatus (BL-10) 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: December 26, 2024 Received: December 26, 2024
Dear Yongfen Yang:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature from "YAN FU -S". The signature includes the date and time of the signature, which is March 13, 2025, at 18:24:57. The time zone is indicated as -04'00'. The signature appears to be an electronic verification of a document or file.
for Tanisha Hithe
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) K243993
Device Name Photon Therapy Apparatus (BL-10)
Indications for Use (Describe)
Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±8nm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (830±8mm 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K243993 - 510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2025-02-26
Submitter's identifications 1.
Name: Xemis Medical Technology (Shenzhen) Co., Ltd.
Address: 1101/1102/1201/1202, Unit 1, Building 2, Hongpeng Building, Tiegang
Community, Xixiang Street, Baoan, Shenzhen, China
Contact person: Yang Yongfen
Title: RA Engineer
E-mail: yangyongfen(@ximisihn.com
Tel: 86-755-23316735
| Trade/Device Name | Photon Therapy Apparatus |
|---|---|
| Model | BL-10 |
| Product Code | GEX |
| Classification Panel | General & Plastic Surgery |
| Regulatory Class | Class II |
| Regulation Number | 21 CFR878.4810 |
| Submission type | Traditional 510(K) |
2. Subject Device Information
Predicate Device 3.
| Device name and model | K number | Manufacturer |
|---|---|---|
| LED Light Therapy Device | K222751 | Xuzhou Kernel MedicalEquipment Co., Ltd. |
| Phototherapy System | K190938 | Shanghai Apolo MedicalTechnology Co., Ltd. |
| Oxylight | K200104 | RAJA Trading Company, Inc. |
Device Description 4.
The photon therapy apparatus (BL-10) use 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 (633±8nm), in the blue light regions of the light spectrum (417±8nm), yellow light area (590±8nm) and infrared light region of light spectrum (835±8nm).
The photon therapy apparatus (BL-10) are equipped with six type of optional irradiators, each of which emits three different colors of light sources. The details of different irradiators are as follows:
Table 1 Specification of different irradiators
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| REF No. | Types of irradiator | Specification |
|---|---|---|
| LT01 | RBY Irradiator | Red/Blue/Yellow light, 3 panels |
| LT02 | RBY Irradiator | Red/Blue/Yellow light, 5 panels |
| LT03 | IBY Irradiator | Infrared/Blue/Yellow light, 3 panels |
| LT04 | IBY Irradiator | Infrared/Blue/Yellow light, 5 panels |
| LT05 | IRY Irradiator | Infrared/Red/Yellow light, 3 panels |
| LT06 | IRY Irradiator | Infrared/Red/Yellow light, 5 panels |
5. Intended use & Indication for use
Photon therapy apparatus use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The red light (633±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.
The blue light (417±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological
conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.
The infrared light (830±8nm 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.
| ProposedDevice | Predicate device | Predicatedevice | Predicatedevice | |
|---|---|---|---|---|
| 510k Number | / | K222751 | K190938 | K200104 |
| Product Code | GEX | GEX | GEX | GEX |
| Proprietary Name | Photon TherapyApparatus | LED LightTherapy Device | PhototherapySystem | Oxylight |
| Model | BL-10 | KN-7000L | HS-770 | / |
| Manufacturer | Xemis MedicalTechnology | Xuzhou KernelMedical | ShanghaiApolo Medical | RAJA TradingCompany, Inc. |
| ProposedDevice | Predicate device | Predicate device | Predicate device | |
| (Shenzhen) Co.,Ltd. | Equipment Co.,Ltd. | TechnologyCo., Ltd. | ||
| Photon TherapyApparatus useof the red, blue,yellow andinfrared regionsof the spectrumis intended toemit energy totreatdermatologicalconditions. | LED LightTherapy Deviceuse of the red,blue, Yellow andinfrared regionsof the spectrumis intended toemit energy totreatdermatologicalconditions. | PhototherapySystems use ofthe red, blueand infraredregions of thespectrum isintended toemit energy totreatdermatologicalconditions. | The Oxylightis intended fordermatologicaluse byphysicians andhealthcareprofessionalsfor thefollowing:LEDTechnology isintended for:-Blue LED –465nm - totreatdermatologicalconditions andspecificallyindicated totreat moderateinflammatoryacnevulgaris.-Red LED625nm- fortreatment ofsuperficial,benignvascular andpigmentedlesions.-Yellow LED590nm -treatment ofperiorbitalwrinkles andrhytides | |
| Indications for Use | The red light(633±8nmwavelength) isgenerallyindicated totreatment ofsuperficial,benign vascular,and pigmentedlesions.The blue light(417±8nmwavelength) isgenerallyindicated totreatdermatologicalconditions andspecificallyindicated totreat moderateinflammatoryacne vulgaris.The yellowlight (590±8nmwavelength) is | The red light(633±10nmwavelength) isgenerallyindicated totreatment ofsuperficial,benign vascular,and pigmentedlesions.The blue light(417±10 nmwavelength) isgenerallyindicated to treatdermatologicalconditions andspecificallyindicated to treatmoderateinflammatoryacne vulgaris.The Yellow light(590±10nmwavelength) isgenerally | The blue light(415nmwavelength) isgenerallyindicated totreatdermatologicalconditions andspecificallyindicated totreat moderateinflammatoryacne vulgarisThe red light(630nmwavelength) isgenerallyindicated totreatment ofsuperficial,benignvascular, andpigmentedlesionsThe infraredlight (835nm | |
| ProposedDevice | Predicate device | Predicatedevice | Predicatedevice | |
| generallyindicated totreatdermatologicalconditions andspecificallyindicated fortreatment ofperiorbitalwrinkles andrhytides.The infraredlight (830±8nmwavelength) isgenerally usefor thetemporary reliefof minor muscleand joint pain,arthritis andmuscle spasm;relievingstiffness;promoting therelaxation ofmuscle tissue;and totemporarilyincrease localbloodcirculationwhere applied. | indicated to treatdermatologicalconditions andspecificallyindicated fortreatment ofperiorbitalwrinkles andrhytides.The infraredlight (835±15nmwavelength) isgenerally use forthe temporaryrelief of minormuscle and jointpain, arthritis andmuscle spasm;relievingstiffness;promoting therelaxation ofmuscle tissue;and totemporarilyincrease localblood circulationwhere applied. | wavelength) isgenerally usefor thetemporaryrelief of minormuscle andjoint pain,arthritis andmuscle spasm;relievingstiffness;promoting therelaxation ofmuscletissue; and totemporarilyincrease localbloodcirculationwhere applied. | ||
| Wavelength(s)(nm) | Red light633±8nmBlue light417±8nmYellow light590±8nm | Red light 633 ±10nmBlue light417±10nmYellow light590±10nm | Red light 630± 15nmBlue light 415± 15nmInfrared 835 ±15nm | Red light625nmBlue light465nmYellow light590nm |
| ProposedDevice | Predicate device | Predicatedevice | Predicatedevice | |
| Infrared830±8nm | Infrared 835 ±15nm | |||
| Panels Type | 3 panel and 5panel.The panels mayemit the threelight(red/yellow/blue, or infrared/yellow/blue, orinfrared/yellow/red)individual or incombination | 5 PanelsThe panels mayemit the threelight(red/blue/infrared, orred/blue/yellow)individual or incombination | 3 panel and 4PanelThe panelsmay emit thethree light(red, blue,infrared)individual orin combination | Three type,each head typehas only onelight. Red,Blue, yellow. |
| Output Power | Each panel hasthree differentkinds of light-emitting diodes,and the energypower of thediode isasfollows:Redlight:1.5 | Each panel hasthree differentkinds of light-emitting diodes,and the energypower of thediode is 0.5W | EachLEDlamp bead has4diodesthatemit differentcolors,theenergy powerof adiode is 3W. | unknown |
| Maximum powerdensity in mW(mW/CM²) | (1)Red:80mW/cm²(2)Blue:100mW/cm2(3)Yellow35W/cm2 | Red light: 20~96 mw/cm2Blue light: 10~120 mw/cm2Yellow light:5~35 mw/cm2 | (1)Red light:115mW/cm2,(2)Blue light:120mW/cm²,(3)IR:70mW/cm²,(4)Red/IR: | (1)Red:100mW/cm²(2)Blue:45mW/cm2(3)Yellow35W/cm2 |
| ProposedDevice | Predicate device | Predicatedevice | Predicatedevice | |
| (4)Infrared:50mW/cm² | Infrared: ≤ 70mw/cm ² | 120mW/cm²,(5)Blue/IR:150mW/cm² | ||
| Standard does inJoules | (1)Red: 96J/cm²(2)Blue:120J/cm²(3)Yellow:42J/cm²(4)Infrared:60J/cm² | Red light:155J/cm2,Blue light:144J/cm2,Yellow light:42J/cm2,IR: 84J/cm2 | (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:120J/cm²(2)Blue:54J/cm²(3)Yellow:42J/cm² |
| Adjustable doserange | (1) Red light: 1-144J/cm²(2) Blue light:1-180J/cm²(3) Yellow light:1-63J/cm²(4) Infrared: 3-90J/cm² | Red light: 20 ~ 96 J/cm²Blue light: 10 ~ 120J/cm²Yellow light: 5 ~ 35 J/cm²Infrared: ≤ 70J/cm²Red/IR: 20 ~ 166J/cm²Blue/IR: 10 ~ 190 J/cm² | (1)Red light:1-242J/cm²,(2)blue light:1-180J/cm²,(3)IR:1-147J/cm²,(4)Red/IR: 1-144J/cm2,(5)Blue/IR:1-180J/cm² | (1)Red light:1-240J/cm2,(2)blue light:1-108J/cm2,(3)YellowIR:1-84J/cm2 |
| Effective irradiationarea: (CM²) | 825cm² and1375cm² | 900 cm² ±10% | 756cm² and1008cm² | 500cm² and860cm² |
| Structural style | Wheeled | Wheeled | Wheeled | Wheeled |
| Structurecomposition | Main frame,irradiator,support arm | Main frame,irradiator, liftingframe | Main frame,irradiator,lifting frame | Irradiator andsupport |
| Power supply | AC 100-240V50/60Hz | AC 100-240V50/60Hz | AC 100-240V50/60Hz | AC 100-240V50/60Hz |
| Treatment time | 20min(Recommendedtreatment time) | 20min(Recommendedtreatment time) | 20min(Recommended treatmenttime) | 20min(Recommended treatmenttime) |
| ProposedDevice | Predicate device | Predicate device | Predicate device | |
| Operation interface | Display Screen | Display Screen | Display Screen | Display Screen |
| Software | Yes | Yes | Yes | Yes |
| Safety classification | Class I | Class I | Class I | Class I |
| 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 60601-2-57IEC 62471 | IEC 60601-1IEC 60601-1-2IEC 60601-2-57IEC 62471 |
6. Summary of Substantial Equivalence
Table 2 Comparison to Predicate Device
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Substantial Equivalence discussion:
The indications for use of the Photon Therapy Apparatus are the same as those for the predicate devices. Most technical specifications of the Photon Therapy Apparatus are either the same or substantially equivalent as compared to the predicate devices. There are no significant technological differences that raise new or different questions of safety or effectiveness.
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Image /page/11/Picture/1 description: The image shows the logo for Xemis. The word "XEMİ" is written in black font, except for the accent mark over the "i", which is red. The logo is simple and modern.
7. Non-clinical tests
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety, electromagnetic compatibility (EMC) and performance
Electrical safety, EMC and performance testing were performed to, and passed, the following standards:
- · ANSI AAMI ES60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- · IEC 60601-1: 2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- · IEC 60601-1-2:2020 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility Requirements and tests
- · IEC 60601-2-57: 2023 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 cosmetic and aesthetic use
- . IEC 62471: 2006 Photobiological safety of lamps and lamp systems
Software Verification and Validation
Software documentation consistent with Basic Documentation Level of concern was submitted in this 510(k). System verification testing presented in this 510(k) demonstrated that all software requirement specifications are met.
Clinical study 8.
Not applicable.
9. Conclusion
Based on comparing to predicate devices, the proposed device of BL-10 are determined to be Substantially Equivalent (SE) to the predicate devices, in respect of safety and effectiveness.
§ 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.