(49 days)
Not Found
No
The 510(k) summary describes a device that uses intense pulsed light and vacuum technology. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or the sections specifically checked for AI/ML terms.
Yes
The device is intended for the treatment of various medical conditions, including benign vascular and pigmented lesions, permanent hair reduction, and acne, which are therapeutic applications.
No
The device's intended use is for "treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne." It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states the system is comprised of a "Main console" and "Treatment Handpiece(s)", which are hardware components. It also describes the delivery of "intense pulsed light" via a handpiece, further indicating a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of various skin conditions (vascular and pigmented lesions, hair reduction, acne) by applying intense pulsed light directly to the patient's skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a system that delivers light to a patient's treatment site. This is consistent with a therapeutic device, not a device that analyzes samples from the body (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Theravant TheraClear System's function is to treat conditions directly on the patient's body.
N/A
Intended Use / Indications for Use
The Theravant TheraClear System is intended for:
- The treatment of benign vascular and pigmented lesions; ●
- Permanent hair reduction;
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild . to moderate inflammatory acne (acne vulgaris).
The TheraClear System is intended for use on all skin types (Fitzpatrick types I-VI).
Product codes
ONF
Device Description
The Theravant System is comprised of the following main components:
- Main console .
- Treatment Handpiece(s) .
The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.
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
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)
Aesthera Isolaz System (K083730)
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
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- 8 2010
Section 1- 510(k) Summary or 510(k) Statement
I. General Information
Submitter:
ﺗﻘ
Theravant Corporation 201 Lindberg Ave Livermore, CA 94551 USA
Contact Person:
Marcy Moore Regulatory Consultant for Theravant Corporation 131 Kelekent Lane Cary, NC 27518 919-363-2432 ph 919-363-0085 fax marcymoore@nc.rr.com
May 14, 2010 Summary Preparation Date:
Names II.
| Trade Name: | TheraClear System |
|---|---|
| Classification: | Class II |
| 21 CFR 878.4810 | |
| Product Code: | ONF |
| Primary Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology |
III. Predicate Device(s)
- Aesthera Isolaz System (K083730); .
IV. Product Description
The Theravant System is comprised of the following main components:
- Main console .
- Treatment Handpiece(s) .
1
The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.
PB 2 of
10/ 415
V. Indications for Use
The Theravant TheraClear System is intended for:
- The treatment of benign vascular and pigmented lesions; ●
- Permanent hair reduction;
- The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild . to moderate inflammatory acne (acne vulgaris).
The TheraClear System is intended for use on all skin types (Fitzpatrick types I-VI).
Rationale for Substantial Equivalence VI.
The TheraClear System shares the identical indications for use as the named predicate(s), and same or similar device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
Safety and Effectiveness Information VII.
The review of the indications for use and technical characteristics demonstrates that the TheraClear System is substantially equivalent to the predicate devices.
VIII. Conclusion
The Theravant System was found to be substantially equivalent to the predicate devices.
The Theravant System shares the identical indications for use as the named predicate(s), and same or similar device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings and body represented by a series of curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Theravant Corporation % Ms. Marcy Moore Regulatory Consultant 131 Kelekent Lane Cary, North Carolina 27518
JUL - 8 2010
Re: K101415
Trade/Device Name: TheraClear 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: ONF Dated: May 19, 2010 Received: May 20, 2010
Dear Ms. Moore:
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.
3
Page 2 - Ms. Marcy Moore
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K10 | 4
Device Name: TheraClear
Indications for Use:
The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including gunsular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all e knowner (Fitzpatrick I-VI).
Prescription Use · > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oli) Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number: K014115
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