JOULE SYSTEM

K180508 · Sciton, Inc · GEX · May 18, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180508
• Device Name: JOULE SYSTEM
• Applicant: Sciton, Inc
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 18, 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 soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: Skin resurfacing treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratosis, surgical scars, scar revision (including acne scars).

Device Story

Joule ProFractional System is a laser-powered surgical device using 2940 nm Er:YAG laser energy. System comprises a console (power supply, cooling system, microprocessor control) and delivery accessories (articulated arm or fiber optic arm with handpiece). Physician operates device via footswitch to deliver optical energy to treatment site; focusing optics enable fractional ablation. Device used in clinical settings for soft tissue procedures; output is laser energy for coagulation, resurfacing, and ablation. Healthcare provider monitors energy delivery via console display. Benefits include precise tissue removal and scar revision. Safety features include remote interlock and required protective eyewear.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological characteristics and performance specifications compared to legally marketed predicate devices.

Technological Characteristics

2940 nm Er:YAG laser; articulated arm delivery; 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 aiming beam.

Indications for Use

Indicated for soft tissue procedures including skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratosis, and scar revision (including acne scars) in dermatology and plastic surgery.

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 2940 Fractional handpiece (K173285)
• SharpLight Technologies Ltd. OmniMax (K111303)

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). 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.

May 18, 2018

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

Re: K180508

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 21, 2018 Received: February 26, 2018

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. 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

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 mediation-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 -S3

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) K180508

Device Name JOULE ProFractional System

#### Indications for Use (Describe)

The Joule 2940 nm ProFractional System with its accessories is intended for use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dernatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi: Telangiectasia: Spider veins: Actinic chelitis: Keloids: Verrucae: Skin tags: Keratoses: Scar revision (including acne scars).

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

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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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: | May 15, 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: | K173285: Joule 2940 Fractional handpiece<br>K111303: SharpLight Technologies Ltd. OmniMax |
| 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 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<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 soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth<br>tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and<br>nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic<br>Surgery: Skin resurfacing treatment of wrinkles, epidermal nevi, telangiectasia,<br>spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratosis,<br>surgical scars, scar revision (including acne scars). |
| 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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| Specification | This Application | | Substantially<br>Equivalent | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| | Joule 2940<br>Fractional<br>Handpiece | StarLight Technologies<br>Ltd. | Joule 2940 Fractional<br>Handpiece | |
| Indications for<br>Use | Coagulation,<br>resurfacing and<br>ablation of soft<br>tissue.<br>Procedures include<br>skin resurfacing and<br>treatment of<br>wrinkles, rhytides,<br>furrows, fine lines,<br>textural irregularities,<br>benign pigmented<br>lesions, and<br>vascular dyschromia | Use in soft tissue (skin,<br>cutaneous tissue,<br>subcutaneous tissue,<br>striated and smooth tissue,<br>muscle, cartilage meniscus,<br>mucous membrane, lymph<br>vessels and nodes; organs,<br>and glands) such as, but not<br>limited to: Dermatology and<br>plastic Surgery: Skin<br>resurfacing Treatment of<br>wrinkles; Epidermal nevi;<br>Telangiectasia; Spider<br>veins; Actinic chelitis;<br>Keloids; Verrucae; Skin<br>tags; Anal tags; Keratoses;<br>Scar revision (including<br>acne scars). | Use in soft tissue (skin,<br>cutaneous tissue,<br>subcutaneous tissue,<br>striated and smooth tissue,<br>muscle, cartilage meniscus,<br>mucous membrane, lymph<br>vessels and nodes; organs,<br>and glands) such as, but not<br>limited to: Dermatology and<br>plastic Surgery: Skin<br>resurfacing Treatment of<br>wrinkles; Epidermal nevi;<br>Telangiectasia; Spider<br>veins; Actinic chelitis;<br>Keloids; Verrucae; Skin<br>tags; Anal tags; Keratoses;<br>Scar revision (including<br>acne scars). | Yes |
| Ref. 510(k) | K173285 | K111303 | K180508 | |
| Energy Source | 2940 nm Er:YAG | 2940 nm Er:YAG | 2940 nm Er:YAG | Yes |
| Spot Size | 1.3x1.3mm to<br>20x20mm | 9.5x9.5mm | 1.3x1.3mm to 20x20mm | Yes |
| Wavelength | 2940 nm | 2940 nm | 2940 nm | Yes |
| Maximum<br>Repetition Rate | Up to 3 Hz | Up to 3 Hz | Up to 3 Hz | Yes |
| Pulse Duration | 0.5 to 1.5 msec | 1 to 1.5 msec | 0.5 to 1.5 msec | Yes |
| Energy | Up to 70<br>mJ/microbeam | 25 mJ/microbeam (7x7dots)<br>and 13 mJ/microbeam<br>(9x9dots) | Up to 70 mJ/microbeam<br>[Up to 25 mJ/microbeam for<br>epidermal nevi,<br>telangiectasia, spider veins,<br>actinic chelitis, keloids,<br>verrucae, skin tags, anal<br>tags, keratosis, scar revision<br>(including acne scars)] | Yes |
| Utilities | 230 VAC/25A, 50/60<br>HZ | 110-220 VAC, 50/60 Hz | 230 VAC/25A, 50/60 Hz | Yes |
| Aiming Beam | Red/Green | | Red/Green | Yes |
| Delivery System | Articulated Arm | Electrical Cable | Articulated Arm | Yes |
| Cooling System | Water to Air | Water to Air | Water to Air | Yes |
| Control System | Microprocessor | Microprocessor | Microprocessor | Yes |
| Energy Monitor | Display Indicates<br>Energy Delivered to<br>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 Connector | Safety Eyewear and<br>Remote Interlock Connector | Yes |
| Console<br>Dimensions | 14" x 21" x 41" high | 17" x 22" x 18" high | 14" x 21" x 41" high | Yes |
| Weight | 200 lbs | 92 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 is 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. |