(110 days)
Not Found
No
The document describes a radiofrequency energy delivery system with standard electrical and mechanical components. There is no mention of AI, ML, image processing, or data-driven decision-making within the device description or performance studies.
Yes
The device is indicated for the non-invasive treatment of wrinkles and rhytids, which constitutes a therapeutic use.
No
The device description clearly states its intended use is for "non-invasive treatment of wrinkles and rhytids" using radiofrequency energy, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines numerous hardware components including a main console, handpieces, and accessories, indicating it is a physical medical device that utilizes radiofrequency energy delivery.
Based on the provided text, the Accent™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures" and the "non-invasive treatment of wrinkles and rhytids." This describes a device used directly on a patient's body for therapeutic purposes.
- Device Description: The description details a system that delivers radiofrequency energy to a patient's treatment site via a handpiece. This is consistent with a device used for physical treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. The Accent™ device is a therapeutic device used for direct treatment.
N/A
Intended Use / Indications for Use
The Accent™ device is intended for use in dermatologic and general surgical procedures.
The Accent™ device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Alma Lasers Accent™ device is comprised of the following main components:
- Main console containing the major electrical components, including the: .
- Control Panel; A
- Radiofrequency (RF) Module; A
- a Power Supply Module;
- Service Panel; A
- A Cooling Module;
- A Handpiece holders;
- A Emergency stop push button;
- A Key switch;
- A RF energy emission visual and audio indicators;
- A Connector ports for the handpieces and power cord:
- A Main circuit breaker; and
- UniPolar (i.e., monopolar) and Bipolar Handpieces incorporating:
- Treatment tip with thermoelectric cooling (TEC) for cooling the treatment ア site during use for patient comfort;
- A Handpiece trigger;
-
Umbilical connection to the main console; and
- Accessories:
- A Cart:
- Water Filling Kit;
- 0 Non-contact thermometer.
The Alma Lasers Accent™ is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.
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)
Clinical information was provided to demonstrate safety and effectiveness. Clinical information demonstrating the safety and effectiveness of the Alma Lasers Accent™ device for the non-invasive treatment of wrinkles and rhytids was provided.
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.
K051214, K031671, K053365, K040135, K033942, K013034
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).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
K 07004
Page 1 of 2
Section 5-510(k) Summary or 510(k) Statement
I. General Information
APR 2 3 2007
Submitter:
Alma Lasers, Ltd. Halamish Street (PO Box 3021), Industrial Park, Caesarea, 38900 ISRAEL
Contact Person:
Tatiana Epstein Regulatory Affairs Manager
Summary Preparation Date: April 20, 2007
II. Names
Device Names:
Accent™
Electrosurgical, Cutting & Coagulation Device & Primary Classification Names: Accessories
III. Predicate Devices
- Lumenis Aluma Skin Renewal System (K051214) .
- Syneron Medical Polaris WR (K031671) .
- Thermage ThermaCool TC (K053365, K040135, and K033942) t
- Thermage ThermaCool IIA (K013034) .
IV. Product Description
The Alma Lasers Accent™ device is comprised of the following main components:
- Main console containing the major electrical components, including the: .
- Control Panel; A
- Radiofrequency (RF) Module; A
- a Power Supply Module;
- Service Panel; A
- A Cooling Module;
- A Handpiece holders;
- A Emergency stop push button;
- A Key switch;
- A RF energy emission visual and audio indicators;
- A Connector ports for the handpieces and power cord:
- A Main circuit breaker; and
- UniPolar (i.e., monopolar) and Bipolar Handpieces incorporating:
- Treatment tip with thermoelectric cooling (TEC) for cooling the treatment ア site during use for patient comfort;
- A Handpiece trigger;
-
Umbilical connection to the main console; and
1
K 070004
Page 2 of (2)
- Accessories:
- A Cart:
- Water Filling Kit;
- 0 Non-contact thermometer.
The Alma Lasers Accent™ is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.
V. Indications for Use
The Accent™ device is intended for use in dermatologic and general surgical procedures.
The Accent™ device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar.
VI. Rationale for Substantial Equivalence
The Alma Lasers Accent™ device shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices. In addition, clinical information was provided to demonstrate safety and effectiveness.
Safety and Effectiveness Information VII.
The review of the indications for use and technical characteristics and clinical information provided demonstrates that the Alma Lasers Accent™ device is substantially equivalent to the predicate devices. Clinical information demonstrating the safety and effectiveness of the Alma Lasers Accent™ device for the non-invasive treatment of wrinkles and rhytids was provided.
VIII. Conclusion
The Alma Lasers Accent™ device was found to be substantially equivalent to the predicate devices.
The Alma Lasers Accent™ device shares the same or similar indications for use, similar design features, and functional features with, and thus 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, resembling a caduceus or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alma Lasers, Ltd. % A. Worden Consulting Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, California 94566
APR 2 3 2007
Re: K070004
Trade/Device Name: Accent™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 29, 2007 Received: April 2, 2007
Dear Ms. Worden:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Anne Worden
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K070004
Device Name: Accent™M
Indications for Use:
The Accent™ device is intended for use in dermatologic and general surgical procedures.
The Accent™ device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar.
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K070604
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)