(76 days)
Not Found
No
The document describes a light-based therapy device with vacuum technology and a needle accessory, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as intended for the "treatment" of several conditions, including various forms of acne and vascular/pigmented lesions, which falls under the definition of a therapeutic device.
No
The Intended Use / Indications for Use section clearly states that the device is intended for "treatment" of various conditions (vascular and pigmented lesions, hair reduction, acne), not for diagnosis.
No
The device description explicitly states it is comprised of a main console and treatment handpiece(s), which are hardware components. It also describes the delivery of intense pulsed light and vacuum technology, 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 and vacuum to the patient's skin. It does not mention any components or processes that analyze biological samples (like blood, urine, tissue, etc.) outside of the body, which is the hallmark of an in vitro diagnostic device.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
In summary, the Theravant Acleara/TheraClear System is a therapeutic device used for treating skin conditions, not a device used for diagnosing diseases or conditions by examining samples outside the body.
N/A
Intended Use / Indications for Use
The Theravant Acleara/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 pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick 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. A modification to the handpiece includes a needle accessory for use during the treatment of inflammatory acne lesions. The modified handpiece does not introduce any changes to the principles of operation as compared to the traditional handpiece. The modified handpiece uses vacuum to confine and stretch the target region, coupled with a fine gauge needle to facilitate the release of sebum from the pilosebaceous unit.
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)
The review of the indications for use and technical characteristics demonstrates that the Acleara System is substantially equivalent to the predicate device. Performance testing, including validation and verification testing, and risk analysis support the safety and effectiveness of the modification.
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
510(k) Summary of Safety and Effectiveness KT23889
MAR 4 2013
General Information I.
Submitter:
Theravant Corporation 455 North Canyon Parkway, Suite B Livermore, CA 94551 USA
Contact Person:
Marcy Moore Regulatory Consultant for Theravant Corporation 131 Kelekent Lane Cary, NC 27518 919-363-2432 ph 919-651-1001 fax marcy@marcymoore.com
December 17, 2012 Summary Preparation Date:
II. Names
Acleara System; TheraClear System Trade Names:
Laser Powered Surgical Instruments Primary Classification Name:
K Number:
III. Predicate Device(s)
- TheraClear System (K101415); .
IV. Product 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
1
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.
A modification to the handpiece includes a needle accessory for use during the treatment of inflammatory acne lesions. The modified handpiece does not introduce any changes to the principles of operation as compared to the traditional handpiece. The modified handpiece uses vacuum to confine and stretch the target region, coupled with a fine gauge needle to facilitate the release of sebum from the pilosebaceous unit.
V. Indications for Use
The device modification does not affect the indications for use, although the modified handpiece is recommended for use in conjunction with the treatment of acne lesions only.
The Theravant Acleara 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 (Firzpatrick types I-VI).
VI. Rationale for Substantial Equivalence
The Acleara modified handpiece insert is substantially equivalent to the Acleara Original handpiece inserts. The basis for the insert modification is a simple means to facilitate the release of sebum from the pilosebaceous unit. To a large extent, this is currently achieved during the vacuum process employed by the Acleara system. Using the same principal as traditional lancing or manual extraction of sebum, the modified insert employs a fine gauge needle to ease the release of sebum during the vacuum process. The use of the modified insert is intended as a complimentary procedure to the current recommended Acleara treatment for acne.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics demonstrates that the Acleara System is substantially equivalent to the predicate device. Performance testing, including validation and verification testing, and risk analysis support the safety and effectiveness of the modification.
VIII. Conclusion
The Handpiece Modification to the Theravant Acleara System does not present new or different risks. The indications for use, device operation, overall technical capabilities remain the same and therefore is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: March 4, 2013
Theravant, Corporation % Ms. Marcy Moore Regulatory Consultant 131 Kelekent Lane Cary, North Carolina 27518
Re: K123889
Trade/Device Name: Acleara/Theraclear 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: January 22, 2013 Received: February 04, 2013
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.
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
3
Page 2 - Ms. Marcy Moore
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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/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) 638-204) or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known): | K123889 |
|---|---|
| --------------------------- | --------- |
Acleara/TheraClear Device Name:
Indications for Use:
The Theravant Acleara/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 pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (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)
Neil R Ogdens 2013.02.28 15:06:29 -05'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123889