(81 days)
Not Found
No
The provided text describes a laser system for soft tissue treatment and does not mention any AI or ML components or functionalities.
Yes
The device is intended for various medical and cosmetic treatments, including skin resurfacing, wrinkle treatment, and scar revision, indicating its use for therapeutic purposes.
No
The provided text describes the device as a "ProFractional System" intended for various dermatological and plastic surgery treatments such as skin resurfacing, treatment of wrinkles, and scar revision. There is no mention of the device being used to diagnose conditions or diseases.
No
The device description explicitly states it consists of a console and laser delivery accessories, including a power supply, cooling system, and articulated arm/fiber optic arm with a handpiece. These are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for treating various skin and soft tissue conditions using laser energy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a laser system that delivers optical energy to the treatment site. This aligns with a therapeutic device, not a device used to examine samples outside the body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to directly treat the patient's tissue.
N/A
Intended Use / Indications for 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 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: Keratoses: Scar revision (including acne scars).
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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: | (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 Marketed | |
| Predicate Device: | K173285: Joule 2940 Fractional handpiece |
| K111303: SharpLight Technologies Ltd. OmniMax | |
| Description of | |
| JOULE ProFractional | |
| System: | 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. | |
| 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). | |
| 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. |
4
| Specification | This Application | | Substantially
Equivalent | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| | Joule 2940
Fractional
Handpiece | StarLight Technologies
Ltd. | Joule 2940 Fractional
Handpiece | |
| 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). | 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
20x20mm | 9.5x9.5mm | 1.3x1.3mm to 20x20mm | Yes |
| Wavelength | 2940 nm | 2940 nm | 2940 nm | Yes |
| Maximum
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
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)] | Yes |
| Utilities | 230 VAC/25A, 50/60
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
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 | 17" x 22" x 18" high | 14" x 21" x 41" high | Yes |
| Weight | 200 lbs | 92 lbs | 200 lbs | |
5
| 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 is 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. |