(429 days)
No
The device description focuses on standard laser technology components and control systems (MCU) without mentioning AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes.
The device is used for various medical procedures such as dermatological treatments, incision, excision, ablation, coagulation, and endovascular procedures, which categorize it as a therapeutic device.
No
The indicated uses of the device (e.g., coagulation, ablation, treatment of lesions, incision, excision) are therapeutic procedures, not diagnostic ones. The device description also focuses on its operational aspects as a laser for tissue manipulation.
No
The device description explicitly details hardware components such as a diode laser, GaAlAs diode bar, cavity resonator, power source, MCU, drive board, temperature system, DC-DC conversion module, current-control circuit, footswitch, remote interlock connector, touch units, display terminal, and optical fiber coupling system. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed for both "CHARISMA" and "REGAL" are all related to surgical and dermatological procedures performed directly on the patient's body. These include coagulation, resurfacing, incision, excision, ablation, vaporization, hemostasis, endovascular procedures, and laser-assisted lipolysis.
- Device Description: The device description details a diode laser system designed to deliver laser energy for these procedures. It describes the components involved in generating and delivering the laser beam.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological samples or any diagnostic purpose based on such analysis.
The device is clearly intended for therapeutic and surgical interventions performed directly on the patient, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin, facial, greatest saphenous vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted on the Medical Diode Laser System, including Electrical safety and electromagnetic compatibility (EMC) and Software Verification and Validation Testing.
-
Electrical safety and electromagnetic compatibility (EMC):
- 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.
The nonclinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device. Clinical testing was not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
3
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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4
510(k) summary K234004
I Submitter
| Device submitter: | Reveal Lasers Ltd. |
|---|---|
| Add.: | 14 Raoul Wallenberg ,Tel Aviv, Israel 6971912 |
| Contact person: | Name: Yoram Levy |
| Qsite, Regulatory Affairs and Quality Systems | |
| Tel: +972 (52) 2792871 | |
| E-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 Plastic |
| Surgery 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 Plastic |
| Surgery 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 Plastic |
| Surgery | |
| 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 Plastic |
| Surgery 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 Plastic |
| Surgery 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
5
K160549 510(k) number:
6
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.
7
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 m |
| NA ≥0.22 | |
| With SMA905 connector | |
| The single used sterile fiber which has | |
| already been registered in U.S.A. is applied. | |
| Transmission system | contact: fibers of 200µm, 400µm, 600µm |
| and 1000µm with SMA905 connector; | |
| Non-contact: fibers and tips | |
| Aiming beam | Diode laser of 650nm, power |