(208 days)
Not Found
No
The summary describes a laser system for dermatological procedures with standard components and controls. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on electrical safety, biocompatibility, and software validation, not AI/ML performance metrics.
Yes
The device is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of various skin conditions like actinic keratosis and benign pigmented lesions, which falls under the definition of therapeutic use.
No
The JOULE 1927nm Laser System is indicated for therapeutic dermatological procedures, not for diagnosing conditions.
No
The device description explicitly states it consists of a console and laser delivery accessories, including hardware components like a power supply, cooling system, and delivery arms/handpiece. It is a physical laser system, not software only.
Based on the provided information, the JOULE 1927nm Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for dermatological procedures requiring the coagulation of soft tissue and treatment of skin lesions. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a laser system with a console, delivery accessories, and a handpiece used to deliver optical energy to a treatment site on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or the analysis of biological samples.
Therefore, the JOULE 1927nm Laser System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The JOULE 1927nm Laser 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
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electromagnetic compatibility testing was performed per standards IEC 60601-1: 2012 reprint, IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-2-22:2007 and IEC 60825-1:2014. Software verification and validation was successfully performed. Patient contacting component was tested for biocompatibility per ISO 10993-1 and was determined to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| 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: | 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 | |
| Predicate Device: | K130193: Solta FraxelDUAL |
| K171009: Lutronic LASEMD Laser System | |
| Description of | |
| JOULE 1927nm | |
| Laser System: | The JOULE 1927nm Laser 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 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). | |
| Technological | |
| Characteristics: | The JOULE 1927nm Laser 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 | Predicate Device | Predicate Device | This Application | Substantially
Equivalent |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| | FraxelDUAL | LASEMD Laser System | JOULE 1927 nm | -- |
| Indications for
Use | The Fraxel 1927 nm laser is
indicated for use in
dermatological procedures
requiring the coagulation of
soft tissue, treatment of actinic
keratosis, and treatment of
pigmented lesions such as,
but not limited to lentigos (age
spots), solar lentigos (sun
spots) and ephelides
(freckles). | The LASEMD 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). | 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). | Yes |
| Ref. 510(k) | K130193 | K171009 | N/A | -- |
| CDRH Laser
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
Width | 7 and 15 mm | 10 mm | 15 mm | Yes |
| Wavelength | 1927 nm | 1927 nm | 1927 nm | Yes |
| Pulse Repetition
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
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 | 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
Performance Data | Electrical safety and electromagnetic compatibility testing was performed per
standards IEC 60601-1: 2012 reprint, IEC 60601-1-2:2007, IEC 60601-1-6:2010,
IEC 60601-2-22:2007 and IEC 60825-1:2014. Software verification and validation was
successfully performed. Patient contacting component was tested for biocompatibility
per ISO 10993-1 and was determined to be biocompatible. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Effectiveness: | The indications for use are based upon the indications for use for predicate systems.
Technologically, the JOULE 1927nm Laser System is substantially equivalent to the
listed predicate devices. Therefore, the risks and benefits for the JOULE 1927nm
Laser System is comparable to the predicate devices. |
| Conclusion: | JOULE 1927nm Laser System shares similar indications for use, design features, and
similar functional features as, and therefore is substantially equivalent to the currently
marketed predicate devices. |