JOULE SYSTEM

K173285 · Sciton, Inc · GEX · Jan 29, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173285
• Device Name: JOULE SYSTEM
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 29, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Joule 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

Device Story

Joule ProFractional System is a laser-powered surgical device for dermatological procedures. It utilizes a 2940 nm Er:YAG laser source to deliver thermal energy to soft tissue via focusing optics. The system comprises a control console (power supply, cooling system, microprocessor) and delivery accessories (articulated arm with handpiece). The physician operates the device using a footswitch to trigger laser emission. The system provides energy monitoring via a display indicating energy delivered to tissue. By performing controlled ablation and coagulation, the device enables skin resurfacing and treatment of various dermatological conditions. It is intended for clinical use by trained healthcare professionals.

Clinical Evidence

Bench testing only. No clinical data presented. Substantial equivalence is based on technological comparison and shared indications for use with legally marketed predicate devices.

Technological Characteristics

2940 nm Er:YAG laser; articulated arm delivery system; water-to-air cooling; microprocessor-controlled; 230 VAC/25A power; spot size 1.3x1.3mm to 20x20mm; pulse duration 0.5-1.5 msec; repetition rate up to 3 Hz; energy up to 70 mJ/microbeam. Safety features include remote interlock and safety eyewear.

Indications for Use

Indicated for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue, including treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

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 (K081352)
• Artisan Aesthetic System (K100270)
• Palomar Icon Aesthetic System (K110907)
• Palomar Icon Aesthetic System (K142376)

Submission Summary (Full Text)

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January 29, 2018

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

Re: K173285

Trade/Device Name: Joule 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: December 29, 2017 Received: January 4, 2018

Dear Mr. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

# Sincerely. Jennifer R. Stevenson -ਟਤ

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K173285

Device Name JOULE ProFractional System

#### Indications for Use (Describe)

The Joule 2940 nm ProFractional System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia.

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

| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M14.9417 2.33333L5.66669 11.6083L1.05835 7L0.33335 7.725L5.66669 13.0583L15.6667 3.05833L14.9417 2.33333Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
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| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="15" rx="2.5" stroke="black" width="15" x="0.5" y="0.5"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### Attachment IV

## 510(k) 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: | January 9, 2018 |
| Device Trade Name: | JOULE ProFractional System |
| 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>K081352: Profile Multi-Platform System<br>K100270: Artisan Aesthetic System<br>K110907: Palomar Icon Aesthetic System<br>K142376: Palomar Icon Aesthetic System |
| Description of<br>JOULE ProFractional<br>System: | The JOULE ProFractional System consists of a console and laser deliver<br>accessories. It uses focusing optics to deliver thermal energy to the treatment site.<br>The control console houses the power supply, cooling system, articulated arm<br>delivery system and/or fiber optic arm delivery system with a handpiece. The<br>user activates laser emission by means of a footswitch. |
| Intended Use: | The Joule 2940 nm ProFractional System with its accessories is intended for use<br>in dermatological procedures requiring coagulation, resurfacing, and ablation of<br>soft tissue. Procedures include skin resurfacing and treatment of wrinkles,<br>rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and<br>vascular dyschromia. |
| Technological<br>Characteristics: | The JOULE 2940 nm ProFractional System 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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| 2940 nm Laser System | | | | | | | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--|
| Specification | Predicate Devices | | | | This Application | Substantially<br>Equivalent | |
| | JOULE Multi-<br>Platform<br>System | Profile<br>ProFractional | Palomar<br>LUX2940<br>Fractional<br>Handpiece | Cynosure | Joule 2940<br>Fractional<br>Handpiece | | |
| Indications for<br>Use | The JOULE<br>2940 nm Multi-<br>Platform System<br>with<br>ProFractional<br>handpiece and<br>delivery system<br>is intended for<br>use in<br>dermatological<br>procedures<br>requiring skin<br>resurfacing,<br>ablation and<br>coagulation of<br>soft tissue. | Coagulation and<br>resurfacing of<br>soft tissue. | Coagulation,<br>resurfacing and<br>ablation of soft<br>tissue, treatment<br>of wrinkles.<br>pigmented lesions<br>and vascular<br>dyschromia. | Coagulation,<br>resurfacing, and<br>ablation of soft tissue.<br>Procedures include<br>skin resurfacing and<br>treatment of wrinkles,<br>rhytides, furrows, fine<br>lines, textural<br>irregularities,<br>pigmented lesions,<br>and vascular<br>dyschromia | Coagulation,<br>resurfacing and<br>ablation of soft tissue.<br>Procedures include<br>skin resurfacing and<br>treatment of wrinkles,<br>rhytides, furrows, fine<br>lines, textural<br>irreqularities, benign<br>pigmented lesions,<br>and vascular<br>dyschromia | Yes | |
| Ref. 510(k) | K101916 | K081352 | K100270, K110907 | K142376 | K173285 | -- | |
| Energy Source | 2940 nm Er:YAG | 2940 nm Er:YAG | 2940 nm Er:YAG | 2940 nm Er:YAG | 2940 nm Er:YAG | Yes | |
| Spot Size | 1.3x1.3mm to<br>20x20mm | Up to 20 x 20<br>mm | Up to 10 x 10 mm | Up to 10 x 10 mm | 1.3x1.3mm to<br>20x20mm | Yes | |
| Wavelength | 2940 nm | 2940 nm | 2940 nm | 2940 nm | 2940 nm | Yes | |
| Maximum<br>Repetition Rate | Up to 3 Hz | Up to 2 Hz | Up to 3 Hz | -- | Up to 3 Hz | Yes | |
| Pulse Duration | 0.5 to 1.5 msec | 0.5 to 1.5 msec | Up to 5 msec | Up to 5 ms | 0.5 to 1.5 msec | Yes | |
| Energy | Up to 70<br>mJ/microbeam | Up to 70<br>mJ/microbeam | Up to 24<br>mJ/microbeam | Up to 70<br>mJ/microbeam | Up to 70<br>mJ/microbeam | Yes | |
| Utilities | 230 VAC/25A,<br>50/60 Hz | 230 VAC/25A,<br>50/60 Hz | 100-240 VAC,<br>50/60 Hz | 100-240 VAC, 50/60<br>Hz | 230 VAC/25A, 50/60<br>Hz | Yes | |
| Aiming Beam | Red/Green | Red/Green | -- | -- | == | Yes | |
| Delivery<br>System | Articulated Arm<br>or Fiber optic | Articulated Arm<br>or Fiber optic | Fiber optic | Fiber optic | Articulated Arm | Yes | |
| Cooling System | Water to Air | Water to Air | Water to Air | Water to Air | Water to Air | Yes | |
| Control System | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Microprocessor | Yes | |
| Energy Monitor | Display Indicates<br>Energy<br>Delivered to<br>Tissue | Display Indicates<br>Energy<br>Delivered to<br>Tissue | Display Indicates<br>Energy Delivered<br>to Tissue | Display Indicates<br>Energy Delivered to<br>Tissue | Display Indicates<br>Energy Delivered to<br>Tissue | Yes | |
| Safety | Safety Eyewear<br>and Remote<br>Interlock<br>Connector | Safety Eyewear<br>and Remote<br>Interlock<br>Connector | -- | == | Safety Eyewear and<br>Remote Interlock<br>Connector | Yes | |
| Console<br>Dimensions | 14" x 21" x 41"<br>high | 14" x 21" x 41"<br>high | -- | 23" x 22" x 41" high | 14" x 21" x 41" high | Yes | |
| Weight | 200 lbs | 200 lbs | 58 Ibs | 135 lbs | 200 lbs | == | |

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| Safety and<br>Effectiveness: | The indications for use are based upon the indications for use for predicate systems.<br>Technologically, the JOULE ProFractional System is substantially equivalent to the<br>listed predicate devices. Therefore, the risks and benefits for the JOULE<br>ProFractional System are comparable to the predicate devices. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | JOULE ProFractional System shares similar indications for use, design features, and<br>similar functional features as, and therefore is substantially equivalent to the currently<br>marketed predicate devices. |