(237 days)
The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.
The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base.
The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction.
The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.
This document describes the FDA's 510(k) premarket notification for the "Diode Laser Therapy System" by Beijing ADSS Development Co., Ltd. A 510(k) submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness de novo through clinical trials, as would be required for a PMA (Premarket Approval) device.
Therefore, the provided document does not contain information typically found in a study proving a device meets acceptance criteria derived from a clinical trial for AI/ML-based medical devices. The device in question is a laser therapy system, not an AI/ML-based device that would require complex performance metrics like sensitivity, specificity, or AUC, nor would it involve human readers, expert ground truth adjudication, or MRMC studies.
The "acceptance criteria" discussed in this document relate to the substantial equivalence to predicate devices and compliance with relevant performance and safety standards for laser devices.
Here's an analysis based on the provided text, addressing the points you raised where applicable to a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" in terms of performance metrics like sensitivity/specificity for an AI/ML device. Instead, "acceptance criteria" are implied by the demonstration of "substantial equivalence" to predicate devices and compliance with recognized international standards for medical electrical equipment and laser products.
The tables provided in Section 6, "Summary of technological characteristics of device compared to the predicate device," serve as the primary comparison metrics to show substantial equivalence.
Acceptance Criteria (Implied by Substantial Equivalence and Standards Compliance) and Reported Device Performance:
| Item | Acceptance Criteria (Predicate Characteristics / Standard Compliance) | Reported Device Performance (Subject Device Characteristics) | Comparison / Outcome |
|---|---|---|---|
| Intended Use / Indications for Use | Predicate K230371 (Alma Soprano Titanium): Temporary hair reduction; permanent reduction in hair regrowth (6, 9, 12 months, all skin types I-VI, including tanned skin) for 810nm and 755nm applicators. Also includes dermatology procedures requiring coagulation, benign vascular and vascular dependent lesions, and topical heating for temporary relief of muscle pain, etc. | Subject Device FG2000-B/FG2000-B Pro: Indicated for temporary hair reduction.Subject Device FG2000-D+/FG2000-D+Pro/FG2000-E: Indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. Suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin. | SE. Subject device's indications are covered by the predicate device (K230371, and K220381 for permanent hair reduction). |
| Laser Type | Diode laser | Diode laser | SE |
| Laser Classification | Class IV | Class IV | SE |
| Laser Wavelength | Predicate K230371: combination of 755nm/810nm/1064nm | Subject Device FG2000-B/FG2000-B Pro: combination of 755nm/808nm/1064nm (SE)Subject Device FG2000-D+/FG2000-D+Pro/FG2000-E: 808nm (SE) | SE (808nm is common in diode lasers and considered equivalent to 810nm for these purposes) |
| Spot Size | Predicate K230371: 2010 mmmm (2cm²) | Subject Device FG2000-B/FG2000-B Pro: 12×16 mm*mm(1.92cm²) | Different. Deemed not to raise new questions of safety/effectiveness during bench testing. |
| Predicate K220381: 15x15mm*mm | Subject Device FG2000-D+/FG2000-D+Pro/FG2000-E: 10×10mm*mm | Different. Deemed not to raise new questions of safety/effectiveness during bench testing. | |
| Pulse Width | Predicate K230371: Up to 200ms | Subject Device FG2000-B/FG2000-B Pro: up to 200ms | SE |
| Predicate K220381: 1-300ms | Subject Device FG2000-D+/FG2000-D+Pro/FG2000-E: 2～100ms | Different. Deemed not to raise new questions of safety/effectiveness during bench testing. | |
| Energy Fluence | Predicate K230371: 2 to 8J/cm2 | Subject Device FG2000-B/FG2000-B Pro: 2~8J/cm2 | SE |
| Predicate K220381: 1～100J/cm2 | Subject Device FG2000-D+/FG2000-D+Pro/FG2000-E: 2～100J/cm2 | Different (Lower minimum). Deemed not to raise new questions of safety/effectiveness during bench testing. | |
| Pulse Frequency | Up to 10 Hz / 1~10Hz | 1~10Hz | SE |
| User Interface | LCD Color Touchscreen | LCD Color Touchscreen | SE |
| Electrical Safety | Comply with ANSI/AAMA ES 60601-1, IEC 60601-2-22 | Comply with ANSI/AAMA ES 60601-1, IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SE |
| Handpiece Tip Material | Sapphire | Quartz crystal | SE (Functionally equivalent for intended purpose) |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Comply with ISO 10993-5, ISO 10993-10 (older versions for predicates), ISO 10993-23 | Comply with ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021 | SE (newer standards complied with, indicating continued safety) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test set was used. Section 8 explicitly states: "There was no clinical testing performed."
- The "test set" for this submission consists of non-clinical bench testing for performance and compliance with relevant standards. The data provenance is implied to be from Beijing ADSS Development Co., Ltd. (China), given their location and the submission coming from them.
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 there was no clinical testing or AI/ML component, there was no need for experts to establish ground truth in the context of diagnostic or treatment efficacy. The "ground truth" for substantial equivalence is the predicate device's proven characteristics and compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical data requiring adjudication was generated.
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 relates to AI/ML device assessment, which this product is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This relates to AI/ML device assessment, which this product is not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established safety and performance of the legally marketed predicate devices and compliance with internationally recognized performance and safety standards (e.g., IEC 60601 series, ISO 10993 series for biocompatibility, IEC 60825-1 for laser safety).
8. The sample size for the training set
- Not applicable. This device does not use a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
In summary:
This document is a 510(k) clearance letter for a diode laser therapy system. The "study" proving the device met "acceptance criteria" was primarily a non-clinical assessment based on:
- Bench testing: To confirm the device's technical specifications and performance (e.g., laser wavelength, pulse characteristics, energy fluence).
- Comparison to predicate devices: Demonstration of "substantial equivalence" in terms of intended use, technological characteristics, and safety features to legally marketed devices.
- Compliance with recognized standards: Adherence to national and international safety and performance standards for medical electrical equipment, laser devices, and biocompatibility.
The "acceptance criteria" are implied by meeting these requirements and showing that any differences from predicate devices do not raise new questions of safety or effectiveness. Clinical testing, human reader studies, and AI/ML specific evaluations (like those mentioned in your prompt) were not part of this clearance process for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
February 20, 2024
Beijing ADSS Development Co., Ltd. Song Ying International Registration Manager Room 609, F6, Building 13, Yard 5 Tianhua Street, Daxing District, Beijing, 102600 China
Re: K231896
Trade/Device Name: Diode Laser Therapy 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: January 17, 2024 Received: January 18, 2024
Dear Song Ying:
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.
{1}------------------------------------------------
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.
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-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,
Shlomit Halachmi
Digitally signed by Shlomit Shlomit Halachmi -S Halachmi -S Date: 2024.02.20 18:39:10-05'00'
For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices
{2}------------------------------------------------
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K231896
Device Name Diode Laser Therapy System
Indications for Use (Describe)
The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.
The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
Submission Number: K231896
1. Submitter's Information
Establishment Registration Information
Beijing ADSS Development Co., Ltd.
Room 609, F6, Building 13, Yard 5 Tianhua Street, Daxing District, Beijing, 102600, P. R. China
Contact Person of applicant Name: Song Ying International Registration Manager TEL: +86 13051615111 Email: irm@adss.com.cn Summary Preparation date: February 18, 2024
2. Device Information
| Trade Name: | Diode Laser Therapy System |
|---|---|
| Model: | FG2000-B/FG2000-B Pro/FG2000-D+/FG2000-D+Pro/ FG2000-E |
| Common name: | Powered Laser Surgical Instrument |
| Regulation Number: | 21 CFR 878.4810 |
| Product code: | GEX |
| Regulation Class: | Class II |
| Review panel: | General & Plastic Surgery |
3. Predicate Device Information
Predicate Device of Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) 510(K) Number: K230371 Trade Name: Alma Soprano Titanium Manufacturer: Alma Lasers Inc.
Predicate Device of Diode Laser Therapy System (Model: FG2000-D+Pro/ FG2000-D+Pro/ FG2000-E) 510(K) Number: K220381 Trade Name: Diode Laser Therapy Systems Beijing LaserTell Medical Co., Ltd Manufacturer:
{5}------------------------------------------------
4. Device description
The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base.
The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction.
The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.
5. Indications for Use
The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.
The Diode Laser Therapy System(Model: FG2000-D+Fro/FG2000-E) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
6. Summary of technological characteristics of device compared to the predicate device
| Item | Subject device | Predicate device(K230371) | Comparison |
|---|---|---|---|
| Device Name | Diode Laser TherapySystem | Alma Soprano Titanium | / |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | Class II | Class II | SE |
| Product Code | GEX | GEX | SE |
| Indication foruse | The Diode Laser TherapySystem is indicated fortemporary hair reduction. | The Soprano Titanium diode laser module isintended for use in dermatology proceduresrequiring coagulation.The indications for use for the SopranoTrio diode laser module include: | SEThe indication ofsubject device iscovered by thepredicate device.The subject |
| The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. | device is only intended to use for temporary hair reduction. | ||
| The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions. | |||
| 810nm ApplicatorSoprano Titanium 810 nm applicator intended use and indications for use:The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include:The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) | |||
| 755nm applicatorSoprano Titanium 755 nm applicator intended use and indications for use:The indications for use for the 755nm Diode Laser Module include:• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.• Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes) | |||
| NIR ApplicatorNIR Applicator intended use and indications for useThe Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) | |||
| spectrum to provide topical heating.The indications for use for NIR Modules are:• Elevating the tissue temperature for thetemporary relief of minor muscle pain and jointpain and stiffness,• The temporary relief of minor joint painassociated with arthritis,• The temporary increase in local circulationwhere applied, and• The relaxation of muscles; may also helpmuscle spasms, minor sprains and strains, andminor muscular back pain. | |||
| Laser Type | Diode laser | Diode laser | SE |
| LaserClassification | Class IV | Class IV | SE |
| LaserWavelength | combination of755nm/808nm/1064nm | combination of 755nm/810nm/1064nm | SE |
| Spot size | 12×16 mm*mm(1.92cm²) | 2010 mmmm (2cm²); | Different 1. |
| Pulse width | up to 200ms | Up to 200ms | SE |
| Energyfluence | 2~8J/cm2 | 2 to 8J/cm2 | SE |
| Pulsefrequency | 1~10Hz | up to 10 Hz | SE |
| Userinterface | LCD Color Touchscreen | LCD Color Touchscreen | SE |
| ElectricalSafety | Comply with ANSI/AAMAES 60601-1,IEC 60601-2-22 | Comply with ANSI/AAMA ES 60601-1,IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22,IEC 60825-1 | Comply with IEC 60601-2-22,IEC 60825-1 | SE |
| Handpiece tipmaterial | Quartz crystal | Sapphire | SE |
| Cytotoxicity | comply with ISO 10993-5:2009 | comply with ISO 10993-5:2009 | SE |
| Sensitization | comply with ISO 10993-10:2021 | comply with ISO 10993-10:2010 | SE |
| Irritation | comply with ISO 10993-23:2021 | comply with ISO 10993-10:2010 | SE |
| Item | Subject device | Predicate device (K220381) | Comparison |
| DeviceName | Diode Laser Therapy System | Diode Laser Therapy Systems | / |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | Class II | Class II | SE |
| ProductCode | GEX | GEX | SE |
| Indication foruse | The Diode Laser Therapy Systemis indicated for permanentreduction in hair regrowth definedas a long term, stable reduction inthe number of hairs re-growingwhen measured at 6,9 and 12months after the completion of atreatment regimen. It is suitable forall skin types (Fitzpatrick skin typeI-VI), including tanned skin. | The Diode Laser Therapy Systemsis intended for hair removal,permanent hair reduction on all skintypes (Fitzpatrick skin type I-VI),including tanned skin.Permanent hair reduction is definedas the long-term, stable reduction inthe number of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatmentregime. | SE |
| Laser Type | Diode laser | Diode laser | SE |
| LaserClassification | Class IV | Class IV | SE |
| LaserWavelength | 808nm | 808nm | SE |
| Spot size | 10×10mm*mm | 15x15mm*mm; | Different 1 |
| Pulse width | 2～100ms | 1-300ms | Different 2 |
| Energyfluence | 2～100J/cm2 | 1～100J/cm2 | Different 3 |
| Pulsefrequency | 1~10Hz | 1~10Hz | SE |
| Userinterface | LCD Color Touchscreen | LCD Color Touchscreen | SE |
| ElectricalSafety | Comply withANSI/AAMA ES 60601-1,IEC 60601-2-22 | Comply withANSI/AAMA ES 60601-1,IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22,IEC 60825-1 | Comply with IEC 60601-2-22,IEC 60825-1 | SE |
| Handpiecetip materia | Quartz crystal | Sapphire | SE |
| Cytotoxicity | comply with ISO 10993-5:2009 | comply with ISO 10993-5:2009 | SE |
| Sensitization | comply with ISO 10993-10:2021 | comply with ISO 10993-10:2010 | SE |
| Irritation | comply with ISO 10993-23: 2021 | comply with ISO 10993-10:2010 | SE |
6.1 For Model: FG2000-B/FG2000-B Pro
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
6.2 For Model: FG2000-D+/FG2000-D+Pro/FG2000-E
{9}------------------------------------------------
7. Non-Clinical Tests Performed for Safety and effectiveness
Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
IEC60601-1:2005, AMD1:2012, AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
AAMI ES60601-1:2005, ES60601-1:2005/AMD1 1:2012, ES60601-1:2005/AMD2:2021 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems IEC 60601-2-22:2007 + A1:2012 +A2:2019 Medical Electrical Equipment - Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60825-1:2014 (Third Edition) Safety of laser products - Part 1: Equipment classification, and requirements
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10: 2021 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation.
8. Clinical Testing Performed
There was no clinical testing performed.
9. Conclusions
The subject device Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) have the similar intended use and similar characteristics as the cleared predicate device. And the bench testing contained in this submission supplied demonstrate that the differences existed do not raise any new questions of safety or effectiveness. Thus, subject device Diode Laser Therapy System is Substantially Equivalent (SE) to the predicate device(Alma Soprano Titanium, K230371).
The subject device Diode Laser Therapy System (Model: FG2000-D+FG2000-D+Pro/FG2000-E) have the same intended use and similar characteristics as the cleared predicate device. And the bench testing contained in this submission supplied demonstrate that the differences existed do not raise any
{10}------------------------------------------------
new questions of safety or effectiveness. Thus, subject device Diode Laser Therapy System is Substantially Equivalent (SE) to the predicate device (K220381).
§ 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.