K Number

Device Name

JOULE SYSTEM

Manufacturer

Sciton, Inc

Date Cleared

2018-01-29

(105 days)

Product Code

GEX

Regulation Number

878.4810

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 Description

The JOULE ProFractional System consists of a console and laser deliver accessories. It uses focusing optics to deliver thermal 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101916, K081352, K100270, K110907, K142376

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser system for dermatological procedures and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is described as being used for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue, including treatment of various skin conditions like wrinkles, textural irregularities, and lesions, which are therapeutic applications.

Diagnostic

The "Intended Use / Indications for Use" section describes the device's purpose for "coagulation, resurfacing, and ablation of soft tissue" and "treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia." These are all therapeutic and aesthetic treatments, not diagnostic processes.

SaMD (Software as a Medical Device)

The device description explicitly states that the system consists of a console and laser delivery accessories, including hardware components like a power supply, cooling system, articulated arm, fiber optic arm, handpiece, and footswitch. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states "dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue." This describes a therapeutic or cosmetic procedure performed directly on the patient's body, not a test performed on a sample (like blood, urine, or tissue) outside of the body.
Device Description: The description details a laser system used to deliver thermal energy to a treatment site on the patient. This aligns with a device used for direct treatment, not for analyzing a sample.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents or assays.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly treat tissue.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GEX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue (dermatological procedures related to skin)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The indications for use are based upon the indications for use for predicate systems. Technologically, the JOULE ProFractional System is substantially equivalent to the listed predicate devices. Therefore, the risks and benefits for the JOULE ProFractional System are comparable to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101916, K081352, K100270, K110907, K142376

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

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);

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

Indications for Use

510(k) Number (if known) K173285

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."

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:	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
Predicate Device:	K101916: Joule Multi-Platform System
K081352: Profile Multi-Platform System
K100270: Artisan Aesthetic System
K110907: Palomar Icon Aesthetic System
K142376: Palomar Icon Aesthetic System
Description of
JOULE ProFractional
System:	The JOULE ProFractional System consists of a console and laser deliver
accessories. It uses focusing optics to deliver thermal 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.
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.
Technological
Characteristics:	The JOULE 2940 nm ProFractional System shares the same indications for use,
and as noted below, shares similar design features (including wavelength, laser
medium and delivery systems, power supply, cooling and control system), functional
features (including power output, repetition rate, energy, spot size and fluence), and
is therefore substantially equivalent to the above legally marketed predicate devices.

2940 nm Laser System
Specification	Predicate Devices				This Application	Substantially
Equivalent
	JOULE Multi-
Platform
System	Profile
ProFractional	Palomar
LUX2940
Fractional
Handpiece	Cynosure	Joule 2940
Fractional
Handpiece
Indications for
Use	The JOULE
2940 nm Multi-
Platform System
with
ProFractional
handpiece and
delivery system
is intended for
use in
dermatological
procedures
requiring skin
resurfacing,
ablation and
coagulation of
soft tissue.	Coagulation and
resurfacing of
soft tissue.	Coagulation,
resurfacing and
ablation of soft
tissue, treatment
of wrinkles.
pigmented lesions
and vascular
dyschromia.	Coagulation,
resurfacing, and
ablation of soft tissue.
Procedures include
skin resurfacing and
treatment of wrinkles,
rhytides, furrows, fine
lines, textural
irregularities,
pigmented lesions,
and vascular
dyschromia	Coagulation,
resurfacing and
ablation of soft tissue.
Procedures include
skin resurfacing and
treatment of wrinkles,
rhytides, furrows, fine
lines, textural
irreqularities, benign
pigmented lesions,
and vascular
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
20x20mm	Up to 20 x 20
mm	Up to 10 x 10 mm	Up to 10 x 10 mm	1.3x1.3mm to
20x20mm	Yes
Wavelength	2940 nm	2940 nm	2940 nm	2940 nm	2940 nm	Yes
Maximum
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
mJ/microbeam	Up to 70
mJ/microbeam	Up to 24
mJ/microbeam	Up to 70
mJ/microbeam	Up to 70
mJ/microbeam	Yes
Utilities	230 VAC/25A,
50/60 Hz	230 VAC/25A,
50/60 Hz	100-240 VAC,
50/60 Hz	100-240 VAC, 50/60
Hz	230 VAC/25A, 50/60
Hz	Yes
Aiming Beam	Red/Green	Red/Green	--	--	==	Yes
Delivery
System	Articulated Arm
or Fiber optic	Articulated Arm
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
Energy
Delivered to
Tissue	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	Yes
Console
Dimensions	14" x 21" x 41"
high	14" x 21" x 41"
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	==

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