(273 days)
No
The summary describes a computerized system with embedded software for controlling RF energy delivery and a massaging mechanism. There is no mention of AI, ML, image processing, or any data-driven algorithms for decision-making or analysis. The performance studies focus on electrical safety and substantial equivalence to predicate devices, not AI/ML performance metrics.
Yes
The device is described as being "intended for use in dermatologic and general surgical procedures," and "indicated for the non-invasive treatment of wrinkles and rhytids" and "temporary reduction in the appearance of cellulite." These are all therapeutic actions.
No
This device is intended for dermatologic and general surgical procedures, specifically for the non-invasive treatment of wrinkles and rhytids, and temporary reduction in the appearance of cellulite. These are therapeutic and aesthetic uses, not diagnostic.
No
The device description clearly outlines multiple hardware components including a console, RF modules, control panel, footswitch, handles, triggers, applicator tips, thermoelectric cooler, umbilical cable, and module connectors. While it mentions embedded software, the device is fundamentally a hardware system controlled by software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly state the device is for "dermatologic and general surgical procedures," "non-invasive treatment of wrinkles and rhytids," and "temporary reduction in the appearance of cellulite." These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details components like handpieces, applicators that contact the skin, and RF energy delivery. This aligns with a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to apply energy and massage to the skin for therapeutic and cosmetic purposes.
N/A
Intended Use / 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. .
Product codes
NUV, GEI, ISA
Device Description
The Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components:
- . Console
- 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.
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)
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.
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
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
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