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).

Device Description

The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver optical energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

AI/ML Overview

This document is a 510(k) premarket notification for the Sciton, Inc. JOULE ProFractional System. It demonstrates substantial equivalence to legally marketed predicate devices, rather than establishing new acceptance criteria or presenting a new clinical study for device performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device is not explicitly present in the provided text.

The document primarily focuses on demonstrating that the JOULE ProFractional System is substantially equivalent to existing devices based on technological characteristics and intended use.

Here's a breakdown of what can be extracted and what is not available based on your request:

1. A table of acceptance criteria and the reported device performance

This document does not present specific acceptance criteria for this new device's performance in a clinical study, nor does it report new device performance data against such criteria. Instead, it compares the technical specifications and intended uses of the JOULE ProFractional System to those of predicate devices to demonstrate substantial equivalence. The table on page 4 provides a comparison of specifications:

Specification	This Application (Joule 2940 Fractional Handpiece)	Predicate Device 1 (Joule 2940 Fractional Handpiece - K173285)	Predicate Device 2 (StarLight Technologies Ltd. - K111303)	This Application (Joule 2940 Fractional Handpiece)	Substantially Equivalent
Indications for Use	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	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; Keratoses; Scar revision (including acne scars).	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; Keratoses; Scar revision (including acne scars).	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; Keratoses; Scar revision (including acne scars).	Yes
Ref. 510(k)	K173285	K111303	K180508	K180508
Energy Source	2940 nm Er:YAG	2940 nm Er:YAG	2940 nm Er:YAG	2940 nm Er:YAG	Yes
Spot Size	1.3x1.3mm to 20x20mm	9.5x9.5mm	1.3x1.3mm to 20x20mm	1.3x1.3mm to 20x20mm	Yes
Wavelength	2940 nm	2940 nm	2940 nm	2940 nm	Yes
Maximum Repetition Rate	Up to 3 Hz	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	0.5 to 1.5 msec	Yes
Energy	Up to 70 mJ/microbeam	25 mJ/microbeam (7x7dots) and 13 mJ/microbeam (9x9dots)	Up to 70 mJ/microbeam [Up to 25 mJ/microbeam for epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision (including acne scars)]	Up to 70 mJ/microbeam [Up to 25 mJ/microbeam for epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision (including acne scars)]	Yes
Utilities	230 VAC/25A, 50/60 HZ	110-220 VAC, 50/60 Hz	230 VAC/25A, 50/60 Hz	230 VAC/25A, 50/60 HZ	Yes
Aiming Beam	Red/Green	(Not specified for predicate 2)	Red/Green	Red/Green	Yes
Delivery System	Articulated Arm	Electrical Cable	Articulated Arm	Articulated Arm	Yes
Cooling System	Water to Air	Water to Air	Water to Air	Water to Air	Yes
Control System	Microprocessor	Microprocessor	Microprocessor	Microprocessor	Yes
Energy Monitor	Display Indicates Energy Delivered to Tissue	Display Indicates Energy Delivered to Tissue	Display Indicates Energy Delivered to Tissue	Display Indicates Energy Delivered to Tissue	Yes
Safety	Safety Eyewear and Remote Interlock Connector	Safety Eyewear and Remote Interlock Connector	Safety Eyewear and Remote Interlock Connector	Safety Eyewear and Remote Interlock Connector	Yes
Console Dimensions	14" x 21" x 41" high	17" x 22" x 18" high	14" x 21" x 41" high	14" x 21" x 41" high	Yes
Weight	200 lbs	92 lbs	200 lbs	200 lbs

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) submission based on substantial equivalence, not a clinical study with a test set. There is no mention of a specific test set, data provenance, or data type (retrospective/prospective) for a clinical performance evaluation of the JOULE ProFractional System.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a test set is discussed in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is discussed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. An MRMC study is beyond the scope of this type of 510(k) submission. There is no mention of AI assistance or human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a laser surgical instrument, not an algorithm. Therefore, standalone performance in the context of an algorithm is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No clinical ground truth is established for this submission. The "ground truth" for this 510(k) is the established performance and safety of the predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and therefore does not have a training set in that context.

9. How the ground truth for the training set was established

Not applicable, for the same reason as point 8.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K180508

Device Name JOULE ProFractional System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Attachment IV

510(k) Summary

Submitter:	Sciton, Inc.
Address:	925 Commercial Street, Palo Alto, CA 94303
Phone:	(650) 493-9155
Fax :	(650) 493-9146
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 MarketedPredicate Device:	K173285: Joule 2940 Fractional handpieceK111303: SharpLight Technologies Ltd. OmniMax
Description ofJOULE ProFractionalSystem:	The JOULE ProFractional System consists of a console and laser deliveraccessories. It uses focusing optics to deliver optical energy to the treatment site.The control console houses the power supply, cooling system, articulated armdelivery system and/or fiber optic arm delivery system with a handpiece. Theuser activates laser emission by means of a footswitch.
Intended Use:	The Joule 2940 nm ProFractional System with its accessories is intended for usein soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smoothtissue, muscle, cartilage meniscus, mucous membrane, lymph vessels andnodes; organs, and glands) such as, but not limited to: Dermatology and PlasticSurgery: 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).
TechnologicalCharacteristics:	The JOULE 2940 nm ProFractional System shares the same indications for use,and as noted below, shares similar design features (including wavelength, lasermedium and delivery systems, power supply, cooling and control system), functionalfeatures (including power output, repetition rate, energy, spot size and fluence), andis therefore substantially equivalent to the above legally marketed predicate devices.

{4}------------------------------------------------

Specification	This Application		SubstantiallyEquivalent
	Joule 2940FractionalHandpiece	StarLight TechnologiesLtd.	Joule 2940 FractionalHandpiece
Indications forUse	Coagulation,resurfacing andablation of softtissue.Procedures includeskin resurfacing andtreatment ofwrinkles, rhytides,furrows, fine lines,textural irregularities,benign pigmentedlesions, andvascular dyschromia	Use in soft tissue (skin,cutaneous tissue,subcutaneous tissue,striated and smooth tissue,muscle, cartilage meniscus,mucous membrane, lymphvessels and nodes; organs,and glands) such as, but notlimited to: Dermatology andplastic Surgery: Skinresurfacing Treatment ofwrinkles; Epidermal nevi;Telangiectasia; Spiderveins; Actinic chelitis;Keloids; Verrucae; Skintags; Anal tags; Keratoses;Scar revision (includingacne scars).	Use in soft tissue (skin,cutaneous tissue,subcutaneous tissue,striated and smooth tissue,muscle, cartilage meniscus,mucous membrane, lymphvessels and nodes; organs,and glands) such as, but notlimited to: Dermatology andplastic Surgery: Skinresurfacing Treatment ofwrinkles; Epidermal nevi;Telangiectasia; Spiderveins; Actinic chelitis;Keloids; Verrucae; Skintags; Anal tags; Keratoses;Scar revision (includingacne 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 to20x20mm	9.5x9.5mm	1.3x1.3mm to 20x20mm	Yes
Wavelength	2940 nm	2940 nm	2940 nm	Yes
MaximumRepetition 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 70mJ/microbeam	25 mJ/microbeam (7x7dots)and 13 mJ/microbeam(9x9dots)	Up to 70 mJ/microbeam[Up to 25 mJ/microbeam forepidermal nevi,telangiectasia, spider veins,actinic chelitis, keloids,verrucae, skin tags, analtags, keratosis, scar revision(including acne scars)]	Yes
Utilities	230 VAC/25A, 50/60HZ	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 IndicatesEnergy Delivered toTissue	Display Indicates EnergyDelivered to Tissue	Display Indicates EnergyDelivered to Tissue	Yes
Safety	Safety Eyewear andRemote InterlockConnector	Safety Eyewear andRemote Interlock Connector	Safety Eyewear andRemote Interlock Connector	Yes
ConsoleDimensions	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

{5}------------------------------------------------

Safety andEffectiveness:	The indications for use are based upon the indications for use for predicate systems.Technologically, the JOULE ProFractional System is substantially equivalent to thelisted predicate devices. Therefore, the risks and benefits for the JOULEProFractional System is comparable to the predicate devices.
Conclusion:	JOULE ProFractional System shares similar indications for use, design features, andsimilar functional features as, and therefore is substantially equivalent to the currentlymarketed predicate devices.

Regulation Number and Section

§ 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.