(11 days)
Not Found
No
The document describes a radiofrequency system for dermatological procedures and does not mention any AI or ML components or functionalities.
No
The device is indicated for non-ablative treatment of wrinkles and rhytids, which are cosmetic concerns rather than medical conditions requiring therapeutic intervention.
No
The "Intended Use / Indications for Use" section states that the device is intended for "dermatologic and general surgical procedures" and for the "non-invasive treatment of wrinkles and rhytids." These are therapeutic or aesthetic applications, not diagnostic ones.
No
The device description clearly lists multiple hardware components (Console, handpieces, control panel, footswitch) in addition to any potential software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures" and "non-invasive treatment of wrinkles and rhytids". This describes a therapeutic or cosmetic treatment applied directly to the patient's body, not a test performed on a sample taken from the body.
- Device Description: The components listed (console, handpieces, control panel, footswitch) are consistent with a device used for applying energy (RF in this case) to tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat the patient's tissue.
N/A
Intended Use / Indications for Use
The Alma Lasers Family of Accent™ RF Systems is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-The Alma Baser Painty of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is comprised of the following main components:
- Console .
- A Bipolar RF handpieces (normal and small-tip)
- A Unipolar RF handpieces (normal and unilarge)
- Control panel .
- 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
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).
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
Page 1 of 2
CONFIDENTIAL
Appendix 7 - 510(k) Summary for the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL]
I. General Information
| Submitter: | Alma Lasers, Ltd.
Halamish Street (PO Box 3021), Industrial Park,
Caesarea, 38900
ISRAEL |
|-----------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Tatiana Epstein
Regulatory Affairs Manager,
Alma Lasers, Ltd. |
| | Anne Worden |
Regulatory Consultant to Alma Lasers, Ltd.
Summary Preparation Date: September 19, 2007
- II. Names
Device Names:
Alma Lasers Family of Accent™ RF Systems
Primary Classification Names:
Electrosurgical cutting and coagulation device and accessories
III. Predicate Devices
- Alma Lasers, Ltd. Accent™ (K070004) .
IV. Product Description
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is comprised of the following main components:
- Console .
- A Bipolar RF handpieces (normal and small-tip)
- A Unipolar RF handpieces (normal and unilarge)
- Control panel .
- Footswitch. .
V. Indications for Use
The Alma Lasers Family of Accent™ RF Systems is intended for use in dermatologic and general surgical procedures.
The Indications for Use of the Accent™ RF Systems are provided in Appendix 4.
1
Image /page/1/Picture/1 description: The image shows the text "Page 2 of 2" in cursive handwriting, with the final "2" circled. Below this, the word "CONFIDENTIAL" is partially visible. The text appears to be part of a document or report, indicating it is the second page of a two-page document.
VI. Rationale for Substantial Equivalence
The Alma Lasers Accent XL™ RF device shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate Accent™ system.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Accent XL™ RF device is substantially equivalent to the predicate Accent™ system.
VIII. Conclusion
The Accent XL™ RF device was found to be substantially equivalent to the predicate Accent™ system.
The Alma Lasers Family of Accent™ RF Devices shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.
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 stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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
0CT 5 * 2007
Re: K072699
Trade/Device Name: Alma Lasers Family of Accent" RF Systems Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 19, 2007 Received: September 24, 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 A. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 3 – Ms. Anne Worden
cc: HF7-401 DMC HFZ-404 510(k) Staff HFZ-410 (DGRND/GSDB) D.O. f/t:GJM:kxl:10-01-07
OC Numbers:
. . . . . .
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
5
510(k) Number (if known): ____K072 699
Device Name: The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL]
Indications for Use:
The Alma Lasers Family of Accent™ RF Systems [Accent XL] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] is indicated for the non-The Alma Baser Painty of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces.
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)
Mark H Millikin
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number