Joule diVa System

K213761 · Sciton, Inc · GEX · Jul 19, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213761
• Device Name: Joule diVa System
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JOULE diVa Laser Device with its accessories is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes). The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

Device Story

JOULE diVa Laser Device is a laser surgical system consisting of a console and delivery accessories (articulated arm or fiber optic). It delivers optical energy (1470 nm and 2940 nm wavelengths) to soft tissue for coagulation, ablation, or cutting. The console houses a power supply, cooling system, and microprocessor control. The physician operates the device via a footswitch. The system uses focusing optics to deliver energy to the treatment site. Output is monitored via a display screen. The device is used in clinical settings (Dermatology, Plastic Surgery, etc.) to perform surgical procedures. By enabling precise tissue interaction, the device assists in skin resurfacing and various surgical applications, providing clinical benefits through controlled tissue removal or coagulation.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance were evaluated using recognized consensus standards including IEC 60601-1 (general safety), IEC 60601-2-22 (laser equipment), IEC 60601-1-2 (EMC), and IEC 60601-1-6 (usability). Biocompatibility of patient-contacting components (Heraeus Quartz Glass Tube) was confirmed via cytotoxicity (ISO 10993-5), irritation (ISO 10993-10/23), and sensitization (ISO 10993-10) testing.

Technological Characteristics

Laser surgical instrument (Class 4). Energy sources: Diode laser (1470 nm) and Erbium YAG laser (2940 nm). Delivery via articulated arm or fiber optic. Cooling: Water-to-air. Control: Microprocessor-based. Patient-contacting material: Heraeus Quartz Glass Tube HLQ 200 V8. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22. Connectivity: Standalone console. Sterilization: Not applicable (not sold sterile).

Indications for Use

Indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes), including dermatological and skin resurfacing procedures.

Regulatory Classification

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.

Predicate Devices

• Joule Multi-Platform System (K101916)
• Profile Multi-Platform System (K060033)
• MCL 31 Dermablate System (K210634)

Submission Summary (Full Text)

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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: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.

July 19, 2022

Sciton, Inc Jay Patel VP of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303

Re: K213761

Trade/Device Name: Joule diVa 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: June 8, 2022 Received: June 9, 2022

Dear Jay Patel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jianting Wang Acting 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) K213761

Device Name JOULE diVa Laser Device

Indications for Use (Describe)

The JOULE diVa Laser Device with its accessories is intended for coagulation, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).

The JOULE diVa Laser System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# K213761 Summary

| Submitter: | Sciton, Inc. |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 925 Commercial Street, Palo Alto, CA 94303 |
| Phone: | [phone] |
| Fax : | [phone] |
| Contact Person: | Jay M. Patel, VP of Regulatory Affairs |
| Date Prepared: | July 16, 2022 |
| Device Trade Name: | JOULE diVa Laser Device |
| Common Name: | Laser Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Product Code: | GEX |
| Legally Marketed<br>Predicate Device: | K101916 Joule Multi-Platform System<br>K060033 Profile Multi-Platform System<br>K210634 MCL 31 Dermablate System |
| Description of JOULE<br>diVa Laser Device: | The JOULE diVa Laser Device consists of a console and laser deliver accessories.<br>It uses focusing optics to deliver optical energy to the treatment site. The control<br>console houses the power supply, cooling system, articulated arm delivery system<br>and/or fiber optic arm delivery system with a handpiece. The user activates laser<br>emission by means of a footswitch. |
| Intended Use: | The JOULE diVa Laser Device with its accessories is intended for coagulation,<br>vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic<br>Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin<br>around the eyes).<br><br>The JOULE diVa Laser System, when used with its micro beam handpieces, is<br>intended for use in Dermatological procedures and Skin resurfacing procedures. |
| Technological<br>Characteristics: | The JOULE diVa Laser Device shares the same indications for use,<br>and as noted below, shares similar design features (including wavelength, laser<br>medium and delivery systems, power supply, cooling and control system), functional<br>features (including power output, repetition rate, energy, spot size and fluence), and<br>is therefore substantially equivalent to the above legally marketed predicate devices. |

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| JOULE diVa Laser Device | | | | | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Specification | Predicate Device | Predicate Device | Predicate Device | This Application | Similar |
| Ref. 510(k) | K101916 | K060033 | K210634 | K213761 | -- |
| Product | Joule Multi-Platform<br>System<br>1470 nm Laser System | Joule Multi-Platform<br>System<br>2940 nm Laser System | MCL 31 Dermablate<br>System | Joule diVa Laser Device | -- |
| Indications for<br>Use | The JOULE 1470 nm<br>Multi-Platform Systems<br>and delivery accessories<br>are intended for delivery<br>of laser light to soft tissue<br>for use in incision,<br>excision, vaporization,<br>ablation, hemostasis or<br>coagulation of soft tissue.<br>The device is indicated<br>for the treatment of reflux<br>of the saphenous veins<br>associated with varicose<br>veins and varicosities.<br>The JOULE 14 70 nm<br>Multi-Platform Systems<br>with Profractional<br>handpiece and delivery<br>system is intended for<br>use in dermatological<br>procedures requiring skin<br>resurfacing and<br>coagulation of soft tissue. | General Surgery<br>The Er: YAG is intended<br>for the surgical<br>incision/excision,<br>vaporization and<br>coagulation of soft tissue<br>during any general surgery<br>application where skin<br>incision, tissue dissection,<br>excision of external tumors<br>and lesions, complete or<br>partial resection of internal<br>organs, tumors, tissue<br>ablation and/or vessel<br>coagulation.<br>Gynecology:<br>Indications include cervical<br>intraepithelial neoplasia<br>(CIN), herpes simplex,<br>endometrial adhesions,<br>cysts and condyloma. | The MCL 31 Dermablate<br>system with its accessories<br>is indicated for coagulation,<br>vaporization, ablation, or<br>cutting of soft tissue (skin) in<br>Dermatology, Plastic<br>Surgery, Oral Surgery, ENT,<br>Gynecology, General<br>Surgery, Podiatry, and<br>Ophthalmology (skin around<br>the eyes).<br>The MCL 31 Dermablate<br>System, when used with its<br>micro beam handpieces, is<br>intended for use in<br>Dermatological procedures<br>and Skin resurfacing<br>procedures. | The JOULE diVa Laser<br>Device with its accessories is<br>intended for coagulation,<br>vaporization, ablation, or<br>cutting of soft tissue (skin) in<br>Dermatology, Plastic Surgery,<br>ENT, Gynecology, General<br>Surgery, Podiatry, and<br>Ophthalmology (skin around<br>the eyes).<br>The JOULE diVa Laser<br>System, when used with its<br>micro beam handpieces, is<br>intended for use in<br>Dermatological procedures<br>and Skin resurfacing<br>procedures. | Yes |
| CDRH Laser<br>Class | Class 4 | Class 4 | Class 4 | Class 4 | Yes |
| Energy<br>Source | Diode Laser, CW, pulsed | Erbium YAG Laser | Erbium YAG Laser | Diode Laser, CW, pulsed<br>Erbium YAG Laser | Yes |
| Laser<br>Wavelength | 1470 nm | 2940 nm | 2940 nm | 1470 nm and 2940 nm | Yes |
| Pulse<br>Duration | Up to 100 sec | 100 $\mu$ s-1000 ms | 100 - 1000 $\mu$ s | Up to 1000 ms | Yes |
| Power | Up to 100 W | 100W | -- | Up to 100 W | Yes |
| Pulse<br>Repetition<br>Rate | -- | 5-60 Hz | 20 Hz | 5-60 Hz | Yes |
| Energy per<br>Pulse | -- | 0.2-7.0 Joules | 2.5 Joules | 0.2-7.0 Joule | Yes |
| Display<br>Screen | Yes | Yes | Yes | Yes | Yes |
| Utilities | 230 VAC/30A, 50/60 Hz | 220 VAC/ 50/60 Hz/ 1φ | -- | 230 VAC/30A, 50/60 Hz | Yes |
| Aiming Beam | Red/Green | Red | Red | Red/Green | Yes |
| Delivery<br>System | Articulated Arm or Fiber<br>Optic | Articulated Arm or Fiber<br>optic | Articulated Arm | Articulated Arm or Fiber optic | Yes |
| Cooling<br>System | Water to Air | Water to Air | Water to Air | Water to Air | Yes |
| Control<br>System | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Yes |
| Energy<br>Monitor | Display Indicates Energy<br>Delivered to Tissue | Display Indicates Energy<br>Delivered to Tissue | Display Indicates Energy<br>Delivered to Tissue | Display Indicates Energy<br>Delivered to Tissue | Yes |
| Safety | Safety Eyewear and<br>Remote Interlock<br>Connector | Safety Eyewear and<br>Remote Interlock<br>Connector | Safety Eyewear and<br>Remote Interlock Connector | Safety Eyewear and Remote<br>Interlock Connector | Yes |
| Console<br>Dimensions | 14" x 21" x 41" high | 14" x 21" x 41" high | 11" x 23" x 37" high | 14" x 21" x 41" high | Yes |
| Weight | 200 lbs | 200 lbs | 165 lbs | 200 lbs | Yes |
| Handpiece | | | | | |
| Photos | Image: handpiece 1 | Image: handpiece 2 | Image: handpiece 3 | Image: handpiece 4 | |
| Spot Size | 430 μm | 425 μm & 600 μm | 450 μm | | Yes |
| Energy per<br>Pulse | < 70 mJ/microbeam | -- | < 70 mJ/microbeam | | Yes |
| Fluence | Up to 48 J/cm² | Up to 35 J/cm² | Up to 48 J/cm² | | Yes |
| Pulse<br>Duration | Up to 1000 ms | -- | Up to 1000 ms | | Yes |
| Distance<br>Indicator | Stainless steel spacer | Dilator | Strengthened quartz dilator | | Yes |
| Aiming Beam | 630 – 680 nm <2.5 mW | 630 – 680 nm <2.5 mW | 630 – 680 nm <2.5 mW | | Yes |
| Output Mode | Fractional pulsed mode…