(125 days)
Not Found
No
The document describes a radiofrequency and mechanical massage device with standard components and no mention of AI or ML capabilities.
No.
The device is intended for temporary reduction in the appearance of cellulite, which is a cosmetic indication rather than a therapeutic one directed at treating a disease or condition.
No
The device is intended for therapeutic purposes (temporary reduction in the appearance of cellulite) through RF energy delivery and mechanical manipulation, not for diagnosing conditions.
No
The device description explicitly details hardware components such as a handpiece, RF emission indicator (LED), thermo-electric cooler, umbilical cable, and handpiece connector with an integrated impedance matching network and memory chip. This indicates it is a physical device with hardware, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The device is intended for use in dermatologic and general surgical procedures to provide temporary reduction in the appearance of cellulite through the application of RF energy and mechanical manipulation of the skin. This is a therapeutic and aesthetic application, not a diagnostic one.
- Device Description: The description details a device that delivers energy and provides mechanical massage to the skin. It does not describe any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
In summary, the device is a therapeutic/aesthetic device used on the body's surface, not a diagnostic device used to analyze samples taken from the body.
N/A
Intended Use / Indications for Use
Intended Use
The Accent UniForm Massager handpiece/module is intended to be used with the Alma Lasers Family of Accent™ RF Systems for use in dermatologic and general surgical procedures.
Indications for Use
The massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide:
• Temporary reduction in the appearance of cellulite.
Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide:
• Temporary reduction in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
NUV, GEI, ISA
Device Description
The Accent UniForm Massager handpiece/module is a cleanable, reusable radiofrequency (RF) energy delivery and skin mechanical manipulation/massage device (accessory) intended for use with the Alma Lasers Family of Accent RF Systems.
The Accent UniForm Massager handpiece/module is comprised of the following main components:
• Handpiece Tip with Massage Ring
• Handpiece Body
•- Handle used for holding the handpiece
•- A RF emission indicator - blue LED illuminates prior to- and during the RF energy emission
•- A Thermo-electric cooler - integrated within the handpiece, provides contact cooling
•- A Umbilical cable - contains hot and cold water tubes (cooling system), RF-power cable and the communication cable that controls the operation of the handpiece
•- A Handpiece connector - connects the handpiece to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip (i-button) that stores information about the handpiece and the parameter settings. It also houses the water tube quick-connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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.
K080300, K053611, K050397, K072699, K070004
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
§ 878.4810 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
082622 Page 6
CONFIDENTIAL
Section 5 - 510(k) Summary or 510(k) Statement
I, General Information
Submitter:
Alma Lasers, Ltd. 14 Halamish Street (PO Box 3021) Industrial Park Caesarea, 38900 Israel
JAN 12 2009
Contact Person:
Tatiana Epstein Regulatory Affairs Manager +972-4-627-5357
Summary Preparation Date:
January 8, 2009
II. Names
Device Name(s):
Accent UniForm Massager Handpiece/Module
Primary Classification Name(s): Massager, vacuum, light induced heating
III. Predicate Devices
- . Cutera Multimodal Cellulite Device (CMMCD) (K080300);
- Biocellulase, Inc. (aka SmoothShapes & Eleme Medical) SmoothShapes (K053611);
- Syneron Medical VelaSmooth Shaper (K050397);
- Alma Lasers Family of Accent RF Systems [Accent, Accent XL] (K072699, K070004).
Product Description IV.
The Accent UniForm Massager handpiece/module is a cleanable, reusable radiofrequency (RF) energy delivery and skin mechanical manipulation/massage device (accessory) intended for use with the Alma Lasers Family of Accent RF Systems.
The Accent UniForm Massager handpiece/module is comprised of the following main components:
- Handpiece Tip with Massage Ring 0
- Handpiece Body
- Handle used for holding the handpiece a
- A RF emission indicator - blue LED illuminates prior to- and during the RF energy emission
- A Thermo-electric cooler - integrated within the handpiece, provides contact cooling
- A Umbilical cable - contains hot and cold water tubes (cooling system), RF-power cable and the communication cable that controls the operation of the handpiece
- A Handpiece connector - connects the handpiece to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip (i-button) that stores information about the handpiece and the parameter settings. It also houses the water tube quick-connectors.
Premarket Notification, 510(k) Submission for: Alma Lasers Accent UniForm Massager (RF Handpiece with Massager) 000016
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ge ② of ②
CONFIDENTIAL
V. Intended Use & Indications for Use
Intended Use
The Accent UniForm Massager handpiece/module is intended to be used with the Alma Lasers Family of Accent™ RF Systems for use in dermatologic and general surgical procedures.
Indications for Use
The massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide:
-
. Temporary reduction in the appearance of cellulite.
Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: -
. Temporary reduction in the appearance of cellulite.
Rationale for Substantial Equivalence VI.
The Accent UniForm Massager handpiece/module shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
.
The review of the indications for use and technical characteristics provided demonstrates that the Accent UniForm Massager handpiece/module is substantially equivalent to the predicate devices.
VIII. Conclusion
The Accent UniForm Massager handpiece/module was found to be substantially equivalent to the predicate devices.
The Accent UniForm Massager handpiece/module shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.
000017
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 12 2009
Alma Lasers Ltd. % A. Worden Consulting Ms. Anne Worden 3637 Bernal Avenue Pleasanton, California 94566
Re: K082622
Trade/Device Name: Accent UniForm Massager Handpiece/Module Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: NUV, GEI, ISA Dated: December 16, 2008 Received: December 22, 2008
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N. Mulhearn
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
Indications for Use Statement
510(k) Number (if known): K082622
Device Name: Accent UniForm Massager Handpiece/Module
Indications for Use:
Intended Use
The Accent UniForm Massager Handpiece/Module is intended to be used with the Alma Lasers Family of Accent™ RF Systems for use in dermatologic and general surgical procedures.
Indications for Use
The massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide:
. Temporary reduction in the appearance of cellulite.
Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide:
Temporary reduction in the appearance of cellulite.
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
ran
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082622
Page 1 of 1
Premarket Notification, 510(k) Submission for: Alma Lasers Accent UniForm Massager (RF Handpiece with Massager)
ﺐ.
Section 4: Indications for Use - Page 4-1 S002 - Page revised 16 Dec 2008
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