Joule System

K182173 · Sciton, Inc · GEX · Mar 6, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K182173
• Device Name: Joule System
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JOULE 1927nm Laser System with its accessories is intended for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

Device Story

Joule 1927nm Laser System is a Class 4 Thulium laser surgical instrument; delivers optical energy to treatment site via articulated arm or fiber optic delivery system with handpiece; user-activated via footswitch. Console houses power supply, water-to-air cooling system, and microprocessor control. Used in clinical settings by healthcare professionals for dermatological procedures; coagulation of soft tissue; treatment of actinic keratosis and benign pigmented lesions. Output energy monitored via display; system includes safety features like remote interlock and eyewear. Benefits include precise tissue coagulation and lesion treatment.

Clinical Evidence

Bench testing only. Performance verified via electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and usability (IEC 60601-1-6). Patient-contacting components confirmed biocompatible per ISO 10993-1. Software verification and validation successfully completed.

Technological Characteristics

Thulium laser (1927 nm); Class 4; 12W power; 0-3 kHz repetition rate; up to 20 mJ energy; up to 20 ms pulse duration. Delivery via articulated arm or fiber optic. Water-to-air cooling. Microprocessor-controlled. Biocompatible patient-contacting components (ISO 10993-1). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation, treatment of actinic keratosis, and treatment of benign pigmented lesions (lentigos, solar lentigos, ephelides).

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

• Solta FraxelDUAL (K130193)
• Lutronic LASEMD Laser System (K171009)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

March 6, 2019

### Re: K182173

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: February 6, 2019 Received: February 8, 2019

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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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.

Digitally signed by Neil R Neil R Ogden -S Ogden -S Date: 2019.03.06 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) K182173

Device Name Joule 1927nm Laser System

#### Indications for Use (Describe)

JOULE 1927nm Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

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

| <div> <object data="checkbox_checked.svg" height="15" type="image/svg+xml" width="15"></object> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
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| <div> <object data="checkbox.svg" height="15" type="image/svg+xml" width="15"></object> 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: | March 6, 2019 |
| Device Trade Name: | JOULE 1927nm Laser 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: | K130193: Solta FraxelDUAL<br>K171009: Lutronic LASEMD Laser System |
| Description of<br>JOULE 1927nm<br>Laser System: | The JOULE 1927nm Laser System consists of a console and laser deliver<br>accessories. It uses focusing optics to deliver optical 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 user<br>activates laser emission by means of a footswitch. |
| Intended Use: | The JOULE 1927nm Laser System with its accessories is intended for use in<br>dermatological procedures requiring the coagulation of soft tissue, treatment of<br>actinic keratosis, and treatment of benign pigmented lesions such as, but not<br>limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles). |
| Technological<br>Characteristics: | The JOULE 1927nm Laser 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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| Specification | Predicate Device | Predicate Device | This Application | Substantially<br>Equivalent |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | FraxelDUAL | LASEMD Laser System | JOULE 1927 nm | -- |
| Indications for<br>Use | The Fraxel 1927 nm laser is<br>indicated for use in<br>dermatological procedures<br>requiring the coagulation of<br>soft tissue, treatment of actinic<br>keratosis, and treatment of<br>pigmented lesions such as,<br>but not limited to lentigos (age<br>spots), solar lentigos (sun<br>spots) and ephelides<br>(freckles). | The LASEMD Laser System<br>is indicated for use in<br>dermatological procedures<br>requiring the coagulation of<br>soft tissue, treatment of<br>actinic keratosis, and<br>treatment of benign<br>pigmented lesions such as,<br>but not limited to lentigos<br>(age spots), solar lentigos<br>(sun spots) and ephelides<br>(freckles). | JOULE 1927nm Laser<br>System is indicated for use in<br>dermatological procedures<br>requiring the coagulation of<br>soft tissue, treatment of<br>actinic keratosis, and<br>treatment of benign<br>pigmented lesions such as,<br>but not limited to lentigos<br>(age spots), solar lentigos<br>(sun spots) and ephelides<br>(freckles). | Yes |
| Ref. 510(k) | K130193 | K171009 | N/A | -- |
| CDRH Laser<br>Class | Class 4 | Class 4 | Class 4 | Yes |
| Laser Type | Thulium Laser | Thulium Laser | Thulium Laser | Yes |
| Energy Source | 1927 nm | 1927 nm | 1927 nm | Yes |
| Spot Size | 256 – 620 μm | 100 - 200 μm | 100 – 620 μm | Yes |
| Maximum Tip<br>Width | 7 and 15 mm | 10 mm | 15 mm | Yes |
| Wavelength | 1927 nm | 1927 nm | 1927 nm | Yes |
| Pulse Repetition<br>Rate | 0 – 3 kHz | 43.5 - 307.7 Hz | 0 – 3 kHz | Yes |
| Pulse Duration | Up to 10 ms | Up to 20 ms | Up to 20 ms | Yes |
| Energy | Up to 20 mJ | Up to 20 mJ | Up to 20 mJ | Yes |
| Utilities | 120-240 VAC,50/60 Hz | 100-240 VAC, 50/60 Hz | 200-240 VAC/25A, 50/60 Hz | Yes |
| Power | 12 W (1927 nm) | 5 W (1927 nm) | 12 W (1927 nm) | Yes |
| Aiming Beam | Red | Red | Red | Yes |
| Delivery System | Fiber optic | Fiber and Handpiece | Articulated Arm or Fiber optic | Yes |
| Emission Control | Footswitch | Footswitch | Footswitch | Yes |
| Display Screen | Yes | Yes | Yes | Yes |
| Cooling System | Air to Air | Air to Air | Water to Air | Yes |
| Control System | Microprocessor | Microprocessor | Microprocessor | Yes |
| Energy Monitor | 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 Remote<br>Interlock Connector | Safety Eyewear and Remote<br>Interlock Connector | Safety Eyewear and Remote<br>Interlock Connector | Yes |
| Console<br>Dimensions | 19" x 18" x 18" high | 16" x 10" x 13" high | 14" x 21" x 41" high | Yes |
| Weight | 55 lbs | 73 lbs | 200 lbs | -- |

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| Non-Clinical<br>Performance Data | Electrical safety and electromagnetic compatibility testing was performed per<br>standards IEC 60601-1: 2012 reprint, IEC 60601-1-2:2007, IEC 60601-1-6:2010,<br>IEC 60601-2-22:2007 and IEC 60825-1:2014. Software verification and validation was<br>successfully performed. Patient contacting component was tested for biocompatibility<br>per ISO 10993-1 and was determined to be biocompatible. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and<br>Effectiveness: | The indications for use are based upon the indications for use for predicate systems.<br>Technologically, the JOULE 1927nm Laser System is substantially equivalent to the<br>listed predicate devices. Therefore, the risks and benefits for the JOULE 1927nm<br>Laser System is comparable to the predicate devices. |
| Conclusion: | JOULE 1927nm Laser 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. |