(429 days)
The intended use of the "CHARISMA" is:
-Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.
The intended use of the "REGAL" is:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.
The document provided is a 510(k) premarket notification for two medical diode laser systems, CHARISMA and REGAL. It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document in the typical sense of a clinical performance study for an AI/software device.
However, I can provide information on the non-clinical tests performed to demonstrate safety and performance equivalence, as these serve as the "acceptance criteria" for this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are compliance with established electrical safety, EMC, and laser safety standards, as well as satisfactory software verification and validation. The "reported device performance" is the demonstration of compliance through non-clinical testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard & Version) | Reported Device Performance (Compliance Status) |
|---|---|---|
| Electrical Safety | IEC60601-1: 2005/(R)2012 | Conformity verified |
| Electromagnetic Compatibility (EMC) | IEC60601-1-2: 2014-02 | Conformity verified |
| Laser Safety | IEC 60825-1: 2007-03 | Conformity verified |
| Laser Equipment Performance | IEC 60601-2-22: 2012-10 | Performance verified |
| Software Verification and Validation | FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) | Testing conducted and documentation provided, demonstrating compliance |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The testing described is non-clinical, involving the physical device and its software being tested against engineering and safety standards, rather than a "test set" of patient data or samples.
- Data Provenance: Not applicable. The testing involves the device itself and its components, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a non-clinical submission. Ground truth, in the context of clinical studies for AI/software, refers to definitive diagnoses or measurements. Here, the "ground truth" is compliance with international safety and performance standards. The "experts" involved would be the engineers and quality assurance personnel conducting and verifying the tests, but their specific number and qualifications are not detailed in this document.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" in the sense of resolving discrepancies in expert opinions on patient data. Compliance with standards is typically determined by objective measurements and verification protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states under "VIII Clinical Testing" that it "is not applicable." This type of study is usually performed for diagnostic AI devices where human performance with and without AI assistance is being compared.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study in the context of AI/software algorithm only was not done. The device is a physical medical laser system, and the non-clinical tests assess the safety and performance of the hardware and integrated software, not a standalone algorithm.
7. The Type of Ground Truth Used
As this is a non-clinical submission, the "ground truth" is compliance with recognized international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22) and FDA guidance for software. These standards define the acceptable limits and behaviors for medical electrical equipment, laser products, and software.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device's safety and performance testing for regulatory clearance, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied in this regulatory submission.
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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.
February 20, 2025
Reveal Lasers Ltd. Mike Collette Director of Regulatory Affairs and Quality Systems Raoul Wallenberg 14a, Aviv, Israel, Tel 6971912 Aviv. 64364 Israel
Re: K234004
Trade/Device Name: Medical diode laser systems (CHARISMA, REGAL) 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: [NOTE: Use date of most recent supplement] Received: February 17, 2025
Dear Mike Collette:
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/ofdocs/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 820.70) 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 (OS) 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 Re"). 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.
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).
{2}------------------------------------------------
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-devices/deviceadvice-comprehensive-regulatory-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,
TANISHA
Digitally signed by
TANISHA L. HITHE -S
L. HITHE -S Date: 2025.02.20
20:13:22-05'00'
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) K234004
Device Name
Medical diode laser systems (CHARISMA, REGAL)
Indications for Use (Describe)
The intended use of the "CHARISMA" is:
-Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.
The intended use of the "REGAL" is:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | --------------------------------------------- |
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510(k) summary K234004
I Submitter
| Device submitter: | Reveal Lasers Ltd. |
|---|---|
| Add.: | 14 Raoul Wallenberg ,Tel Aviv, Israel 6971912 |
| Contact person: | Name: Yoram LevyQsite, Regulatory Affairs and Quality SystemsTel: +972 (52) 2792871E-mail: yoram@qsitemed.com |
II Device
| Trade Name of device: | Medical diode laser systems |
|---|---|
| Model | REGAL, CHARISMA |
| Regulation name: | Laser Surgical Instrument for Use in General and PlasticSurgery and in Dermatology |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Classification: | Class II, 21 CFR 878.4810 |
| Primary Product Code: | GEX |
| Review Panel: | General & Plastic Surgery |
| Submission number: | K234004 |
III Predicate Device
| Predicate Device 1 | |
|---|---|
| Trade name: | LaserME |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Regulation number: | 21 CFR 878.4810 |
| Regulation name: | Laser Surgical Instrument for Use in General and PlasticSurgery and In Dermatology |
| Regulatory class: | Class II |
| Product code: | GEX |
| Submitter: | Neauvia North America |
| 510(k) number: | K230077 |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Regulation number: | 21 CFR 878.4810 |
| Regulation name: | GEX-Powered Laser Surgical Instrument, General and PlasticSurgery |
| Regulatory class: | Class II |
| Product code: | GEX |
| Submitter: | Fotona d.o.o |
| 510(k) number: | K193656 |
| Predicate Device 3 | |
| Trade name: | Alma Diode Tabletop Laser |
| Regulation number: | 21 CFR 878.4810 |
| Regulation name: | Laser Surgical Instrument for Use in General and PlasticSurgery and in Dermatology |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Regulatory class: | Class II |
| Product code: | GEX |
| Submitter: | Alma Lasers, Ltd, |
| 510(k) number: | K160952 |
| Reference Predicate Device | |
| Trade name: | Medical diode laser systems |
| Classification name: | POWERED LASER SURGICAL INSTRUMENT |
| Regulation number: | 21 CFR 878.4810 |
| Regulation name: | Laser Surgical Instrument for Use in General and PlasticSurgery and In Dermatology |
| Regulatory class: | Class II |
| Product code: | GEX |
| Submitter: | Wuhan Gigaa Optronics Technology Co., Ltd |
| Predicate Device 2 | |
|---|---|
| Trade name: | Foton |
na SkyPulse Laser Platform
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K160549 510(k) number:
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IV Device description
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.
The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber.
MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and currentcontrol circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.
Image /page/6/Figure/4 description: This image is a block diagram of a laser system. The diagram includes components such as a foot switch, remote interlock connector, power supply, MCU, LCD, information input, current control, fiber/scanning galvanometer, laser output, DC-DC power, laser diode, working temperature control, and temperature control system. The MCU is connected to the foot switch, remote interlock connector, LCD, information input, and current control. The power supply is connected to the remote interlock connector, DC-DC power, and working temperature control.
The block diagram shows the diode laser system mechanism. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current.
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The operating power supply is the power source of the whole system, it supplies power for the MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. The MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.
Specifications
Model: REGAL
(Temperature is 5℃40℃, relative humidity is no more than 80%, and atmospheric pressure is 860hPa 1060hPa.)
| Laser type | GaAIAs diode laser |
|---|---|
| Model | REGAL |
| Wavelength | 1470nm±10nm |
| Output power | 1-15W(±10%) |
| St of Output power | ≤10% |
| Rp of Output power | ≤10% |
| Operation mode | CW, single pulse, repeat pulse |
| Beam divergence | Working beam: 25°Aiming beam: 25° |
| Pulse width | 10ms-2.5s |
| Pulserepetition rate | 0.2Hz-50 Hz |
| Application systems | Fiber core diameter ≥200 µ mNA ≥0.22With SMA905 connectorThe single used sterile fiber which hasalready been registered in U.S.A. is applied. |
| Transmission system | contact: fibers of 200µm, 400µm, 600µmand 1000µm with SMA905 connector;Non-contact: fibers and tips |
| Aiming beam | Diode laser of 650nm, power<2mW,adjustable brightness. |
| Operation interface | Color LCD touch screen |
| Power supply | ~100-240V, 50-60Hz, 350VA |
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| Laser Class | 4 |
|---|---|
| Safety classification | Class I Type B |
| Cooling | Air |
| FUSE | F5AH250VP |
| Dimensions | 440(W)*402(L)*230(H)mm |
| Weight | 13 kg |
| Waterproof level | IPX1 |
| Footswitch Waterproof level | IPX8 |
| Operating Environment | Temperature is 5°C |
| Storage Environment | Temperature is -20°C |
Model: CHARISMA
(Temperature is 5℃30℃, relative humidity is no more than 80%, and atmospheric pressure is 860hPa 1060hPa.)
General mode
| Laser type | GaAIAs diode laser |
|---|---|
| Model | CHARISMA |
| Wavelength | 1470nm±10nm |
| Output power | 0.5W-15.0W (±10%) |
| St of Output power | ≤10% |
| Rp of Output power | ≤10% |
| Operation mode | CW, single pulse, repeat pulse |
| Beam divergence | Working beam: 25°Aiming beam: 25° |
| Pulse width | 10ms-2.5s |
| Pulserepetition rate | 0.2Hz-50Hz |
| Application systems | Fiber core diameter ≥200µmNA ≥0.22 |
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| With SMA905 connectorThe single used sterile fiber which has alreadybeen registered in U.S.A. is applied. | |
|---|---|
| Transmission system | contact: fibers of 200μm, 400μm, 600μm withSMA905 connector;Non-contact: fibers |
| Aiming beam | Diode laser of 650nm, power<2mW, adjustablebrightness. |
| Operation interface | Color LCD touch screen |
| Power supply | ~100-240V, 50-60Hz, 350VA |
| Laser Class | 4 |
| Safety classification | Class I Type B |
| Cooling | Air |
| FUSE | F5AH250V |
| Dimensions | 285(W)*370(L)*1035(H)mm |
| Weight | 30 kg |
| Waterproof level | IPX0 |
| Footswitch Waterproof level | IPX8 |
| Operating Environment | Temperature is 5℃ |
| Storage Environment | Temperature is -20°C |
BeautyScan mode
| Laser type | GaAlAs diode laser |
|---|---|
| Model | CHARISMA |
| Wavelength | 1470nm±10nm |
| Output power | 2W (±10%) |
| Energy density (energy per microbeam) | up to 50mJ |
| Number of microbeams | Up to 70 |
| Pulse rate / Repetition rate | 0.5-10Hz |
| Applicator window | 5X5 - 18X18mm |
| Operation mode | Repeat pulse |
| Beam divergence | Working beam: 25° |
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| Aiming beam: 25° | |
|---|---|
| Pulse width | 10ms-25ms |
| Operation mode | repeat pulse |
| Application systems | Scanning galvanometer |
| Transmission system | contact: fibers of 200µm with SMA905 connector;Non-contact: fibers |
| Aiming beam | Diode laser of 650nm, power<2mW, adjustable |
| brightness. | |
| Operation interface | Color LCD touch screen |
| Power supply | ~100-240V, 50-60Hz, 350VA |
| Laser Class | 4 |
| Safety classification | Class I Type B |
| Cooling | Air |
| FUSE | F5AH250V |
| Dimensions | 285(W)*370(L)*1035(H)mm |
| Weight | 30 kg |
| Waterproof level | IPX0 |
| Footswitch Waterproof level | IPX8 |
| Operating Environment | Temperature is 5°C |
| Storage Environment | Temperature is -20°C |
V Indications for use
The intended use of the "CHARISMA" is:
-Dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.
{11}------------------------------------------------
The intended use of the "REGAL" is:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux
-Further indicated for laser assisted lipolysis.
VI Comparison of technological characteristics with the predicate devices
The Medical Diode Laser System has the same intended use and principal operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Medical Diode Laser System and predicate devices do not alter suitability of the proposed device for its intended use.
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| Item | Proposed device | Predicate device 1(K230077) | Predicate device 2(K193656) | Predicate device 3(K160952) | ReferencePredicate device(K160549) | Discussion |
|---|---|---|---|---|---|---|
| Medical diode lasersystems | LaserME | Fotona SkyPulseLaser Platform | Alma 1470nmdiode tabletoplaser | VELAS II -15D | ||
| Product Code | GEX | GEX | GEX | GEX | GEX | Identical |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Classification | Class II | Class II | Class II | Class II | Class II | Identical |
| Indication for Use | -Dermatologicalprocedures requiringcoagulation of softtissue and skinresurfacingprocedures. furtherindicated for treatmentof benign pigmentedlesions, such as, butnot limited to lentigines(age spots), solarlentigos (sun spots),melasma, dyschromia,and for treatment offacial wrinkles and finelines.-Incision, excision,ablation, vaporization,hemostasis and/orcoagulation of softtissue-Endovascularcoagulation and | The LaserMe isintended for use indermatologicalprocedures requiringcoagulation of softtissue and skinresurfacingprocedures. TheLaserMe is furtherindicated fortreatment of benignpigmented lesions,such as, but notlimited to lentigines(age spots), solarlentigos (sun spots),melasma,dyschromia, and fortreatment of facialwrinkles and finelines. | 1470 nm DiodeLaser: -Incision,excision, ablation,vaporization,hemostasis and/orcoagulation of softtissue-Endovascularcoagulation andendovenousocclusion of thegreatestsaphenous vein inpatients withsuperficial veinreflux | -The Alma 1470nm diode tabletoplaser is indicatedfor use inendovenousocclusion of thegreatersaphenous vein inpatients withsuperficial veinreflux. The Alma1470 nm diodetabletop laser isfurther indicatedfor laser assistedlipolysis. | VELAS II -15D" isindicated for thetreatment ofreflux of thesaphenous veinsassociated withvaricose veins andvaricosities. | SubstantialEquivalenceIndication for Useclaimed by Proposeddevice has beencovered by Predicatedevice (K230077),(K193656),(K160952) and(K160549). |
| endovenous occlusionof the greatestsaphenous vein inpatients withsuperficial vein reflux-Further indicated forlaser assistedlipolysis. | ||||||
| Laser Classification | diode laser | diode laser | diode laser | diode laser | diode laser | Identical |
| Wavelength | 1470nm±10nm | 1470 ±20nm | 1470nm | 1470nm | 1470nm | Identical |
| Energy density (energyper microbeam)(BeautyScan Mode) | up to 50mJ | up to 50mJ | / | / | / | Identical |
| Number of microbeams(BeautyScan Mode) | up to 70 | up to 70 | / | / | / | Identical |
| Applicator window in(mm) (BeautyScanMode) | 5X5 - 18X18mm | 12x12mm | / | / | / | Similar |
| Output power | General Mode: 0.5W-15.0W (±10%)BeautyScan Mode:2W (±10%) | Up to 2 W | Up to 22 W | 15W | 1-15W | General Mode:Similar;BeautyScan Mode:substantiallyequivalent (within therange of K230077);clinical needs can bemet. |
| Pulse width | 10ms-2.5s (General mode)10ms-25ms(beautyScan mode) | 3ms~30ms | 10ms - 10 s | 10-990ms | 10ms-2.5s | Similar |
Table 1 Substantial equivalence discussion -- CHARISMA
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| Operation Mode | CW, single pulse,repeat pulse (Generalmode)Repeat pulse(beautyScan mode) | pulse | CW | Continuous wave,singlepulse, pulsed | CW, single pulse,repeat pulse | Identical |
|---|---|---|---|---|---|---|
| Operation interface | Color LCD touchscreen | LCD touch screen | Touch screencontrol | LCD touch screen | Color LCD touchscreen | Identical |
| Repetition rate | General Mode: 0.2Hz-50 HzBeautyScan Mode:0.5-10Hz | Up to 18 Hz | CW or up to 100 Hz | / | 0.2Hz-50Hz | Similar |
| Aiming Beam | Diode laser of 650nm,power < 2mW, /adjustable brightness. | / | / | 635nm | Diode laser of635/532nm, powermax. < 5mW,adjustablebrightness | Identical |
| Delivery system | Fiber delivery | Fiber delivery | Fiber delivery | Fiber delivery | Fiber delivery | Identical |
| Power Supply | ~100-240V, 50-60Hz,350VA | 112-240 VAC,/50/60Hz | / | 100-240, V AC 50-60 Hz | 100-240VAC,50/60Hz,350VA | Similar |
Discussion:
As for General mode:
Clinical: Indication for Use claimed by Proposed device (K160952), (K160549) and (K193656) which depends on product performance, and this difference does not affect safety and effectiveness.
Technology: The subject device has the same vavelengths of diode laser to achieve its intended use. The operation mode, laser classification, operation interiaal to the predicate or the reference device. The main differences are output power, pulse width and repetition rate.
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-Output power: The Proposed device has a power output range of 0.5W-15.0W, similar to Predicate device (K160549); also, similar to Predicate device (K160952): 15W.
-Pulse width: The pulse width of the subject device: 10ms-2.5s, which is identical to the Reference device (K160549); Somewhat different from Predicate device, but within the scope of what Predicate device claims.
-Repetition rate: Repetition rate of the subject device: 0.2Hz-50Hz, which is identical to the Reference device(K160549), Somewhat different from Predicate device, but within the scope of the Predicate device claim.
As for BeautyScan Mode
Clinical: Indication for Use claimed by the been covered by Predicate device (K23007) which depends on product performance and this difference does not affect safety and effectiveness.
Technology:
The subject device has the same laser classification, wavelength, same operation mode, energy per microbeam) and number of microbeams to achieve its intended use. (Compare with the K230077).
The comparative analysis of core technical parameters is as follows:
-Applicator window in (mm): applicator window of the subject device K23007 is 12:12mm. The minimum applicator window of subject device. The maximal applicator window of subject device is sightly bigger than the predicate device. The subject device has more precise treatment area. But all of them are intended to meet raise different questions of safety and effectiveness than the predicate device. Therefore, it is substantially equivalent.
- Output power of the subject device is 2N, predicate device K230077 is up to 2W. The output power of the subject device is within the range of the predicate device (K23007). All of them are intended to meet clinical needs, and it doesn't raise of safety and effectiveness than the predicate device. Therefore, it is substantially equivalent.
-Pulse width of the subject device is 10ms- 25ms, predicate device K230077 is 3-30ms. The pubject device is within the range of predicate device (K230077). The pulse width is intended to meet clinical needs, and it doesn't raise different questions of safety and effectiveness than the predicate device. Therefore, it is substantially equivalent.
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-Repetition rate: repetition rate of the subject device is 0.5-10Hz, predicate device K230077 is up to 18 Hz. The repettion rate of subject device is within the range of predicate device (K230077). The repetition rate is intended to meet clinical needs, and it doesn't raise different questions of safety and effectiveness than the predicate device. Therefore, it is substantially equivalent.
Conclusion: The subject device has the same intended use and operation principle, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differe and predicate devices do not alter suitability of the proposed device for its intended use.
| Item | Proposed deviceMedical diode laser systems | Predicate device(K193656)SkyPulse LaserPlatform | Predicate device(K160952)Alma 1470nm diode tabletoplaser | Predicate device(K160549)VELAS II -15D | Discussion |
|---|---|---|---|---|---|
| Product Code | GEX | GEX | GEX | GEX | Identical |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Classification | Class II | Class II | Class II | Class II | Identical |
| Indication for Use | - Incision, excision, ablation,vaporization, hemostasisand/or coagulation of softtissue- Endovascular coagulationand endovenous occlusion ofthe greatest saphenous veinin patients with superficialvein reflux- Further indicated for laserassisted lipolysis. | 1470 nm Diode Laser: -Incision, excision,ablation, vaporization,hemostasis and/orcoagulation of softtissue -Endovascularcoagulation andendovenous occlusionof the greatestsaphenous vein inpatients with superficialvein reflux | -The Alma 1470 nm diodetabletop laser is indicated foruse in endovenous occlusionof the greatersaphenous vein in patientswith superficial vein reflux.The Alma 1470 nm diodetabletop laser isfurther indicated forlaser assisted lipolysis. | VELAS II -15D isindicated for thetreatment ofreflux of the saphenousveins associated withvaricose veins andvaricosities. | SubstantialEquivalenceIndication for Use claimedby Proposed device hasbeen covered by Predicatedevice(K160952),(K160549) and (K193656) |
| Laser Classification | diode laser | diode laser | diode laser | diode laser | Identical |
| Wavelength | 1470nm+10nm | 1470nm | 1470nm | 1470nm | Identical |
| Table 2 Substantial equivalence discussion -- REGAL | |||
|---|---|---|---|
| ----------------------------------------------------- | -- | -- | -- |
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| Output power | 1-15W(±10%) | Up to 22 W | 15w | 1-15W | Similar |
|---|---|---|---|---|---|
| Pulse width | 10ms-2.5s | 10ms – 10s | 10-990ms | 10ms-2.5s | Similar |
| Operation Mode | CW, single pulse, repeatpulse | CW | Continuous wave, singlepulse, pulsed | CW, single pulse, repeatpulse | SubstantialEquivalence |
| Operation interface | Color LCD touch screen | Touch screen control | LCD touch screen | Color LCD touch screen | Identical |
| Repetition rate | 0.2Hz-50 Hz | CW or up to 100 Hz | / | 0.2Hz-50Hz | Similar |
| Aiming Beam | Diode laser of 650nm, power< 2mW, adjustable /brightness. | 635nm | Diode laser of635/532nm, power max.< 5mW, adjustablebrightness | Similar | |
| Delivery system | It is recommended to use thedisposable sterile fiber(K140470, OBERON GmbHFiber Technologies)registered in U.S.A.The fiber parameter mustsatisfy the following:Bare fiber, long as 3mFiber core diameter:200μm/400μm/600μmNA ≥0.22With SMA905 connectorSingle used | Fiber delivery | Alma Diode Tabletop Laser | It is recommended to use thedisposable sterile fiber (K124003, MED-Fibers, Inc.) registered inU.S.A.The parameters mustmeet the followingrequirements:Bare fiber, long as 3mFiber core diameter:600µmNA ≥0.22With SMA905 connectorSingle used | Similar |
| Power Supply | ~100-240V, 50-60Hz, 350VA | / | 100-240, V AC 50-60 Hz | 100-240VAC, 50/60Hz,350VA | Similar |
Discussion:
Clinical: Indication for Use claimed by Proposed device has been covered by Predicate device (K160549) and (K193656) which
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depends on product performance, and this difference does not affect safety and effectiveness.
Technology: The subject device has the same wavelengths of diode laser to achieve its intended use. The operation mode, laser classification, operation intertical to the predicate or the reference device. The main differences are output power, pulse width and repetition rate.
-Output power: The Proposed device has a power output range of 1W-15.0W, same as Predicate to Predicate device (K160952): 15W.
-Pulse width: The pulse width of the subject 10ms-2.5s, which is identical to the Reference device (K160549); Somewhat different from Predicate device, but within the scope of the Predicate device claim.
-Repetition rate: Repetition rate of the subject device: 0.2Hz-50Hz, which is identical to the Reference device (K160549), somewhat different from Predicate device, but within the scope of what predicate device claims
Material: The fiber in contact with the subject device has been approved in K140470.
Conclusion: The subject device has the same intended use and operation principle, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the subject and predicate devices do not alter suitability of the proposed device for its intended use.
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VII Summary of Non-clinical tests:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Medical Diode Laser System.
- Verify the conformity of the proposed devices with the requirements of IEC60601-1: 2005/(R)2012 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
Verify the conformity of the proposed devices with the requirements of IEC60601-1-2: i 2014-02 (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility).
. Verify the conformity of the proposed devices to IEC 60825-1: 2007-03 (Safety of laser products - Part 1: Equipment classification and requirements).
Verify the performance of the proposed devices according to IEC 60601-2-22: 2012- । 10 (Medical electrical equipment Part 2: Particular Requirements for basic safety and essential performance of surgical, cosmetic, therapeutic, and diagnostic laser equipment).
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. "The software for this device was considered as a "moderate" level of concern.
VIII Clinical Testing
lt is not applicable.
IX Conclusion
The Medical Diode Laser System is substantially equivalent to its predicate devices. The nonclinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.