Who is the manufacturer of MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM?

Alma Lasers, Inc. filed the 510(k) submission for MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM (K101147).

What is the FDA product code for MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM?

NUV. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM?

Accent™ (K070004); Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] (K072699); Accent Uniform Massager Handpiece/Module (K082622).

Who can help prepare an FDA 510(k) submission like MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM

K101147 · Alma Lasers, Inc. · NUV · Jan 21, 2011 · General, Plastic Surgery

Device Facts

Record ID	K101147
Device Name	MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
Applicant	Alma Lasers, Inc.
Product Code	NUV · General, Plastic Surgery
Decision Date	Jan 21, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with unipolar and bipolar handpieces. The massager component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide: Temporary reduction in the appearance of cellulite. Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide: Temporary reduction in the appearance of cellulite.

Device Story

Computerized RF system delivering energy to skin via interchangeable handpieces (Bipolar, Unipolar, UniForm). System console includes control panel, footswitch, and module connectors. Modules feature integrated thermoelectric cooling, RF emission indicators, and memory chips for parameter storage. UniForm module combines RF energy with mechanical massage. Used in clinical settings by healthcare providers for dermatologic/surgical procedures. Provider selects parameters via GUI; triggers RF emission via handpiece. Integrated impedance matching network ensures energy delivery. Benefits include non-invasive wrinkle reduction and temporary cellulite appearance improvement.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (High-frequency surgery equipment) demonstrated.

Technological Characteristics

Radiofrequency (RF) energy delivery at 40.68 MHz. System includes console, footswitch, and handpieces (Bipolar, Unipolar, UniForm). Features integrated thermoelectric cooling (TEC) and impedance matching network (IMN). Modules contain memory chips for parameter storage. Electrical requirements: 110-120 V, 50-60 Hz, 5A. Software-controlled GUI.

Indications for Use

Indicated for non-invasive treatment of wrinkles and rhytids in adults using combined unipolar and bipolar RF handpieces; also indicated for temporary reduction in the appearance of cellulite using the UniForm handpiece (massage or combined RF/massage).

Regulatory Classification

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.

Predicate Devices

Accent™ (K070004)
Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] (K072699)
Accent Uniform Massager Handpiece/Module (K082622)

Related Devices

K070004 — ACCENT · Alma Lasers , Ltd. · Apr 23, 2007
K090580 — THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES · Solta Medical, Inc. · Jun 26, 2009
K170758 — Thermage FLX System and Accessories · Solta Medical · Sep 22, 2017
K173759 — Thermage CPT System and Accessories · Solta Medical · Jan 8, 2018
K120513 — GLOW BY ENDYMED · Endymed Medical, Ltd. · May 8, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ K101147 Pg 1 of 4 ## Appendix 7-510(k) Summary for Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] JAN 2 1 2011 #### I. General Information | Sponsor/ 510(k) Owner | Sponsor | | | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------------------------------------------------| | Address and Establishment Registration # | Alma Lasers, Inc. 485 Half Day Rd. Suite No. 100 Buffalo Grove, IL 68900, USA FDA Registration #: 3004167969 | | | | | Tatiana Epstein VP RA Alma Lasers, Inc. | Telephone: Facsimile: Email: | (224 ) 377-2011 (224 ) 377-2050 tatianae@almalasers.com | | Contact Person: | Main Contact: Tatiana Epstein VP RA Alma Lasers, Inc. | Telephone: Facsimile: Email: | (224) 377-2011 (224 ) 377-2050 tatianae@almalasers.com | | | Secondary Contact: Avi Farbstein EVP and GM North America Alma Lasers, Inc. | Telephone: Facsimile: Email: | (224) 377-2011 (224) 377-2050 Avi.Farbstein@almalasers.com | Summary Preparation Date: January 20, 2011 - II. Names Modified Alma Lasers Family of Accent™ Device Names: Radiofrequency (RF) Systems {Accent, Accent XL, Accent Elite] Primary Classification Electrosurgical Cutting and Coagulation Device & Names: Accessories; Massager, vacuum, light induced heating; Electric therapeutic massager #### III. Predicate Devices - · Accent™ (K070004), cleared 04/23/2007, - · Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] (K072699), cleared 09/19/2007 and - · Accent Uniform Massager Handpiece/Module (K082622), cleared 01/12/2009. ### IV. Product Description The Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components: - . Console {1}------------------------------------------------ - a Bipolar RF module - A Unipolar RF module (UniLarge) - A UniForm (RF and Massage) module - . Control panel - Footswitch. . Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components: - . Handle - used for holding the module - . Trigger - activates the radiofrequency energy emission when pressed in Ready mode - Applicator tip establishes contact with the patient's skin . - . Thermoelectric cooler - integrated within the module, provides internal module cooling - . RF emission indicator - blue LED illuminates prior to- and during RF emission - Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module - . Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings. The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application. The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation. ### V. Intended Use and Indications for Use ### Intended Use The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures. ### Indications for Use The Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with unipolar and bipolar handpieces. The massager component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide: - Temporary reduction in the appearance of cellulite. . Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] to provide: - Temporary reduction in the appearance of cellulite. . {2}------------------------------------------------ ાન ન ે. જેવી સ ### VI. Rationale for Substantial Equivalence The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] shares the same indications for use, operation principle, technical and functional capabilities, and therefore is substantially equivalent to the predicate Accent™ Family of RF Systems. Determination of substantial equivalence is based on an assessment of non-clinical performance data. | Characteristic | K101147 Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] | K072699 Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] | K070004 Accent ™ Alma Lasers | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code & Regulation No. | GEI - Electrosurgical, Cutting and Coagulation Device & Accessories; 878.4400 | GEI - Electrosurgical, Cutting and Coagulation Device & Accessories; 878.4400 | GEI - Electrosurgical, Cutting and Coagulation Device & Accessories; 878.4400 | | Intended Use | Massager, vacuum, light induced heating NUV; 878.4810 Massager, therapeutic, electric ISA; 890.5660 Intended for use in dermatologic and general surgical procedures | Massager, vacuum, light induced heating NUV; 878.4810 Massager, therapeutic, electric ISA; 890.5660 Intended for use in dermatologic and general surgical procedures | Intended for use in dermatologic and general surgical procedures | | Indications for Use | Indicated for: • The non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces • Temporary reduction in the appearance of cellulite by the use of the massage component or simultaneous application of the RF energy and mechanical manipulation of the skin | Indicated for: • The non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces • Temporary reduction in the appearance of cellulite by the use of the massage component or simultaneous application of the RF energy and mechanical manipulation of the skin | Indicated for: • The non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces | | Treatment Energy | • Radio frequency (RF) | • Radio frequency (RF) | • Radio frequency (RF) | | RF Frequency | 40,680 MHz | 40,680 MHz | 40,680 MHz | | RF Output Power & Delivery Devices | | | | | | | • UniPolar | • UniPolar | | | • UniLarge | • UniLarge | | | • UniPolar | • UniForm ▶ Massager + RF ▶ RF alone | • UniForm ▶ Massager + RF ▶ RF alone | | | • BiPolar | • BiPolar | • BiPolar | • BiPolar | | Characteristic | K101147 Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] | K072699 Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL] | K070004 Accent ™ Alma Lasers | | Energy Output Mode(s) | • UniPolar (i.e. Monopolar) - volumetric heating • BiPolar - superficial heating | • UniPolar (i.e. Monopolar) - volumetric heating • BiPolar - superficial heating | • UniPolar (i.e. Monopolar) - volumetric heating • BiPolar - superficial heating | | Handpiece Dimensions (mm) | • UniLarge 159 x 158 • BiPolar 153.3 x 158 • UniForm 176 x 185 | • UniPolar 159 x 158 • UniLarge • BiPolar 153.3 x 158 • UniForm 176 x 185 | • UniPolar 169 x 205 • BiPolar 167 x 203 | | Module Connection | • Umbilical cable • Detachable with a memory chip | • Umbilical cable • Detachable with a memory chip | • Umbilical cable • Permanently connected (hard-wired) | | RF Electrode TEC Cooling | Yes | Yes | Yes | | Electrical Reqs | 110-120 V, 50-60 Hz, 5A | 110-120 V, 50-60 Hz, 5A | 110-120 V, 50-60 Hz, 5A | | Console Size ["] Weight [lb] | 12 x 25 x 14 36.5 | 26 x 17 x 16 55 | 21 x 17 x 38 110 | Comparison with the Predicate Devices Appendix 7: 510(k) Summary - Page 3 510 (k) Premarket Notification for: Alma Lasers Accent Family of RF Systems [Accent XL, Accent Elite Models] {3}------------------------------------------------ Performance Testing The following safety performance testing was performed and submitted as part of the 510(k) premarket notification submission: - IEC 60601-1-2: 2004: Medical electrical equipment Part 1: General requirements for safety: Electromagnetic compatibility - IEC 60601-1:1988, Amendment 1:1991, Amendment 2:1995 Medical electrical equipment Part 1: > General requirements for safety - IEC 60601-2-2:2006 Medical electrical equipment Part 2-2: Particular requirements for the basic safety 5 and essential performance of high frequency surgery equipment and high frequency surgical accessories The results of the performance testing of the Accent Elite system show compliance with applicable FDA Recognized Consensus Standards. The review of the indications for use, technical characteristics and performance testing data provided demonstrates that the Accent Elite RF System is substantially equivalent to the predicate Accent™ RF systems, is safe and effective, and performs at least as safely and effectively as the predicate Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] for the intended use and indications. ### VII. Conclusion The Alma Lasers Accent Elite RF System shares the same indications for use, similar design, performance and functional features as the predicate Accent™ RF Systems. The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is found to be substantially equivalent to the predicate Alma Lasers Family of Accent™ RF Systems. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Alma Lasers, Inc. % Ms. Tatiana Epstein 485 Half Day Rd., Suite #100 Buffalo Grove, Illinois 60089 # JAN 2 1 201 Re: K101147 Trade/Device Name: Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] 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: NUV, GEI, ISA Dated: January 10, 2011 Received: January 13, 2011 Dear Ms. Epstein: : ・・ 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 {5}------------------------------------------------ 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 (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/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/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) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. N. Melkerson Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number (if known): ### Device Name: Modified Alma Lasers Family of Accent™ RF Systems Accent, Accent XL, Accent Elite| Indications for Use: The Modified Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces. The massage component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] to provide: � Temporary reduction in the appearance of cellulite. Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent™ RF Systems [Accent XL, Accent Elite] 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) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hannel Plany (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K101147 Page 1 of 1