(190 days)
Not Found
No
The document describes a laser system for soft tissue and nail treatment, focusing on the laser technology and its physical components. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is indicated for medical treatments such as ablation, vaporization, incision, excision, coagulation of soft tissue, and the temporary increase of clear nail in patients with onychomycosis, all of which are therapeutic interventions.
No
The description of the JOULE ClearSense Laser System focuses entirely on its therapeutic functions—ablation, vaporization, incision, excision, coagulation, and heating tissue to destroy targets. There is no mention of it being used to detect, diagnose, monitor, or assess a medical condition.
No
The device description explicitly lists hardware components such as a control console, foot switch, articulated arm, and handpiece.
Based on the provided information, the JOULE ClearSense Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- JOULE ClearSense Function: The JOULE ClearSense Laser System is a therapeutic device that uses laser energy to directly treat soft tissue conditions and onychomycosis. It is applied externally to the patient's body and does not involve the analysis of samples taken from the body.
The description clearly outlines its use for ablation, vaporization, incision, excision, and coagulation of soft tissue, as well as for the temporary increase of clear nail in patients with onychomycosis. These are all direct treatment modalities, not diagnostic tests performed on samples.
N/A
Intended Use / Indications for Use
The JOULE ClearSense Laser System is indicated for ablation, vaporization, incision, excision and coagulation of soft tissue, including:
- Matrixectomy .
- Periungual and subengual warts ●
- Planter warts .
- Radical nail excision ●
- . Neuromas
It is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Product codes (comma separated list FDA assigned to the subject device)
GEX, PDZ
Device Description
The JOULE ClearSense Laser System is a transportable medical device used for the treatment of temporary increase in clear nail in patients with onychomycosis. It uses Nd:YAG laser with a wavelength of 1064 nm.
ClearSense uses the laser energy to heat the target to a temperature that is sufficient to destroy it, but not to the point that the heat damages skin and surrounding tissue.
The ClearSense system consists of a control console, a foot switch, articulated. arm and a handpiece with a stainless steel guide tip (spacer) attached at its end.
Control Console houses the power supply, control electronics, cooling system and optics to direct the laser beam to the input of the articulated arm.
The following specifications list significant physical and performance characteristics of this device:
Laser Medium: Nd:YAG
Laser Wavelength: 1064 nm
Energy per Pulse: 20 - 3500 mJ
Max Power: ≤ 100 W
Spot Size: 1 mm
Output Mode: Pulsed
Aiming Beam Wavelength: 630 - 680 nm
Aiming Beam Power: ≤ 2.5 mW
Rated Voltage: 200-240 V~
Rated Frequency: 50/60 Hz
Rated Current: 25 A
Classification: Class I, Type BF
Laser Output: Class IV
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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): 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
K11148/3
pg 1 of 3
DEC - 7 2011
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: | September 26, 2011 | |
| Device Trade Name: | JOULE ClearSense Laser System | |
| Common Name: | Laser Powered Surgical Device (and Accessories) | |
| Classification: | 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 | ||
| Legally Marketed | ||
| Predicate Device: | K103626: Cutera GenesisPlus Laser System | |
| K093547: PinPointe FootLaser | ||
| K093545: PinPointe FootLaser | ||
| Description of | ||
| JOULE ClearSense | ||
| Laser System: | The JOULE ClearSense Laser System is a transportable medical device used for the treatment of temporary increase in clear nail in patients with onychomycosis. It uses Nd:YAG laser with a wavelength of 1064 nm. |
ClearSense uses the laser energy to heat the target to a temperature that is sufficient to destroy it, but not to the point that the heat damages skin and surrounding tissue.
The ClearSense system consists of a control console, a foot switch, articulated. arm and a handpiece with a stainless steel guide tip (spacer) attached at its end.
Control Console houses the power supply, control electronics, cooling system and optics to direct the laser beam to the input of the articulated arm.
The following specifications list significant physical and performance characteristics of this device: | |
| | | |
| | Laser Medium | Nd:YAG |
| | Laser Wavelength | 1064 nm |
| | Energy per Pulse | 20 - 3500 mJ |
| | Max Power | ≤ 100 W |
| | Spot Size | 1 mm |
| | Output Mode | Pulsed |
| | Aiming Beam Wavelength | 630 - 680 nm |
| | Aiming Beam Power | ≤ 2.5 mW |
| Rated Voltage | 200-240 V~ | |
| Rated Frequency | 50/60 Hz | |
| Rated Current | 25 A | |
| Classification | Class I, Type BF | |
| Laser Output | Class IV | |
1
(111483 Pg 2 of 3
Intended Use:
The JOULE ClearSense Laser System is indicated for ablation, vaporization, incision, excision and coagulation of soft tissue, including:
- · Matrixectomy
- · Periungual and subengual warts
- · Planter warts
- · Radical nail excision
- · Neuromas
It is also indicated for use for the temporary increase of clear nail in patients with cnychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Technological Characteristics: The JOULE ClearSense 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.
| Specification | JOULE
ClearSense
Laser System | Cutera
GenesisPlus
Laser | PinPointe
FootLaser |
|------------------|-------------------------------------------------|-------------------------------------------------|----------------------------------------------|
| Ref. 510(k) | K111483 | K103626 | K093547,
K093545 |
| Wavelength | 1064 nm Nd:YAG | 1064 nm Nd:YAG | 1064 nm Nd:YAG |
| Aiming Beam | 630 - 680 nm
(≤ 2.5 mW) | 630 - 680 nm
(≤ 2.5 mW) | 630 - 680 nm
(≤ 2.5 mW) |
| Energy per Pulse | 20 - 3500 mJ | 20 - 3500 mJ | 20 - 3500 mJ |
| Fluence | 25.5 J/cm2 | 25.5 J/cm2 | 25.5 J/cm2 |
| Max Power | ≤ 100 W | ≤ 100 W | ≤ 100 W |
| Pulse Duration | 100 - 3000 µsec | 100 - 3000 µsec | 100 - 3000 µsec |
| Spot Size | 1 mm*
(up to 13 mm for
other indications) | 1 mm*
(up to 13 mm for
other indications) | 1 mm*
(other spot sizes
not published) |
| Output Mode | Pulsed, multimode | Pulsed, multimode | Pulsed, multimode |
| Repetition Rate | 5 - 100 Hz | 5 - 100 Hz | 5 - 100 Hz |
| Laser Media | Flashlamp
pumped solid
state rod | Flashlamp
pumped solid
state rod | Flashlamp
pumped solid
state rod |
| User Interface | LCD touchscreen | LCD touchscreen | LCD touchscreen |
- for increase in clear nail
Safety and Effectiveness: The indications for use are based upon the indications for use for predicate systems. Technologically, the JOULE ClearSense Laser System is substantially equivalent to the listed predicate devices. Therefore, the risks and benefits for the JOULE ClearSense Laser System are comparable to the predicate devices.
2
1
pg. 3 of 3
Conclusion:
The JOULE ClearSense Laser System shares similar inclications for use, design
features, and similar functional features as, and therefore is substantially equivalent to, the currently marketed predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left and top portions of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Sciton, Inc. % Mr. Jay M. Patel Vice President of Regulatory Affairs 925 Commercial Street Palo Alto, California 94303
MAY 13 2013
Re: K111483
Trade/Device Name: JOULE ClearSense Laser 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: PDZ, GEX Dated: November 21, 2011 Received: December 01, 2011
Dear Mr. Patel:
This letter corrects our substantially equivalent letter of December 07, 2011.
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 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.
4
Page 2 - Mr. Jay M. Patel
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours. FOR
Peter D. Rúmm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment III
Statement of Indications for Use
| 510(k) Number (if known): | K111483 |
|---|---|
| --------------------------- | --------- |
pg 1 of 1
| Device Name: | JOULE ClearSense Laser System |
|---|---|
| -------------- | ------------------------------- |
Indications for Use:
The JOULE ClearSense Laser System is indicated for ablation, vaporization, incision, excision and coagulation of soft tissue, including:
- Matrixectomy .
- Periungual and subengual warts ●
- Planter warts .
- Radical nail excision ●
- . Neuromas
It is also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Neil R. Doyle firma
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
111483 510(k) Number.
× Prescription Use (Per 21CFR801)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)