(158 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description focuses on RF energy delivery and tips.
Yes
The device is used for non-invasive treatment of wrinkles/rhytids and for dermatological procedures requiring ablation and resurfacing of the skin, which constitute therapeutic interventions.
No
This device is intended for dermatologic and general surgical procedures, specifically for the non-invasive treatment of wrinkles and rhytids, and for skin ablation and resurfacing. It does not mention diagnosis, disease detection, or measurement of physiological parameters for diagnostic purposes.
No
The device description explicitly states it includes "radiofrequency (RF) energy delivery devices (accessory)" and "Pixel RF Tips," which are hardware components. The intended use also describes a physical procedure involving energy delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The intended use and indications clearly state that the device is for dermatologic and general surgical procedures, specifically for the non-invasive treatment of wrinkles and rhytids, and for dermatological procedures requiring ablation and resurfacing of the skin. These are all procedures performed on the body, not on samples taken from the body.
- Device Description: The device description details a radiofrequency energy delivery system and tips used for applying energy to the skin. This aligns with a therapeutic or surgical device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended Use
The Alma Lasers family of Accent RF Systems (Accent XL, Accent Elite) with Unipolar and Bipolar Handpieces are intended for use in dermatologic and general surgical procedures.
Indications for Use
The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the noninvasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Accent Pixel RF Tips include cleanable, sterilizable, multiple use radiofrequency (RF) energy delivery devices (accessory) intended for use with the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite]. These Pixel RF Tips are also available as single use, disposable products.
The Accent Pixel RF Tips are comprised of the following main components:
- Pixel Stationary Tip .
- Pixel Roller Tip .
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)
Animal and human clinical data were submitted to substantiate product performance.
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.
K072699, K070004, K101147, K073572, K090025, K083461, K101510, K120513
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
Section 5-510(k) Summary or 510(k) Statement
K121150
Page 1 of 8
SEP 21 2012
| I. General Information | |
|---|---|
| Submitter: | Alma Lasers, Inc. |
| 485 Half Day Road Suite 100 | |
| Buffalo Grove IL 60089 | |
| Contact Person: | Kathy Maynor - Regulatory |
| 352-586-3113 (cell) | |
| Summary Preparation Date: | June 28, 2012 |
| II. Names | |
|---|---|
| Device Name(s): | Accent Pixel RF Tips |
| Primary Classification Name(s): | Electrosurgical cutting and coagulation device and accessories |
III. Predicate Devices#### Predicate Devices III.
・
- Alma Lasers Family of Accent RF Systems [Accent, Accent Elite] (K072699, K070004, . K101147)
- Syneron Medical Matrix RF Applicator (K073572, K090025) .
- EndyMed RF Applicator (K083461, K101510, K120513) .
1
Page 2 of (8)
Product Description IV.
The Accent Pixel RF Tips include cleanable, sterilizable, multiple use radiofrequency (RF) energy delivery devices (accessory) intended for use with the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite]. These Pixel RF Tips are also available as single use, disposable products.
The Accent Pixel RF Tips are comprised of the following main components:
- Pixel Stationary Tip .
- Pixel Roller Tip .
- V. Intended Use & Indications for Use
Intended Use
The Alma Lasers family of Accent RF Systems (Accent XL, Accent Elite) with Unipolar and Bipolar Handpieces are intended for use in dermatologic and general surgical procedures.
Indications for Use
The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the noninvasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
VI. Rationale for Substantial Equivalence
The Accent Pixel RF Tips shares the same or similar indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices. Additionally, animal and human clinical data were submitted to substantiate product performance.
2
| | K0XXXX | K072699, K070004,
K101147 | K073572, K090025 | K083461, K101510, K120513 |
|----------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|
| | Alma Lasers, Ltd. | | Syneron Medical | EndyMed |
| | Family of Accent RF Pixel Tips with
PixelRF Module/ Handpiece | Alma Lasers Family of
Accent RF Systems
[Accent, Accent XL,
Accent Elite] (w/ UniPolar
& BiPolar Handpieces] | Matrix RF Applicator | RF applicator |
| Characteristic | | | | |
| Product Code | | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery |
| Regulation | | • NUV,GEI, ISA 21 CFR
878.4810 | • GEI, OUH - 21 CFR 878.4400 | • GEI, OUH - 21 CFR 878.4400 |
| Intended Use | | Intended for use in
dermatologic and general
surgical procedures | Intended for use in
dermatologic and general
surgical procedures | Intended for use in
dermatologic and general
surgical procedures |
:
Section 5: Page 3
.
Premarket Notification, Special 510(k) Submission for
Alma Lasers Accent Pixel® Tips
.
K 121150
:
.• •
39 (દ
12115
3
| K0XXXX | K072699, K070004,
K101147 | K073572, K090025 | K083461, K101510, K120513 | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Alma Lasers, Ltd. | | Syneron Medical | EndyMed | |
| Family of Accent RF Pixel Tips with PixelRF Module/ Handpiece | Alma Lasers Family of Accent RF Systems
[Accent, Accent XL,
Accent Elite] (w/ UniPolar
& BiPolar Handpieces] | Matrix RF Applicator | RF applicator | K121150
Page |
| Characteris
tics | The Alma Lasers family of Accent RF
Systems (Accent, Accent XL, Accent
Elite) with Unipolar and Bipolar
Handpieces are intended for use in
dermatologic and general surgical
procedures: | The Matrix RF Applicator
is intended for
dermatological procedures
requiring ablation
and resurfacing of the skin,
and for the treatment of
facial wrinkles. | The Glow by EndyMed is a
noninvasive device intended
for use in Dermatologic and
General Surgical procedures.-
The TC applicator is indicated
for mild to moderate facial
wrinkles and rhytides. | |
| Indications
for Use | Indicated for: The non-
invasive treatment of
wrinkles and rhytids using
a combined treatment with
Unipolar and Bipolar
handpieces | | The FSR applicator is
indicated for Dermatological
procedures requiring ablation
and resurfacing of the skin. | |
| | The Unipolar and Bipolar handpieces,
when used as a combined treatment,
are indicated for the non-invasive
treatment of wrinkles and rhytids. | | | |
| | The Pixel RF Tips (stationary and
rolling), when used with the unipolar
handpiece, are indicated for
dermatological procedures requiring
ablation and resurfacing of the skin. | | | |
| | Supported by animal histology data
- section 19 - and human clinical
data - section 20. | | | |
:
:
.
Premarket Notification, Special 510(k) Submission for
Alma Lasers Accent Pixel" Tips
Section 5: Page 4
al (જે) 4 e
4
| | K0XXXX | K072699, K070004,
K101147 | K073572, K090025 | K083461, K101510, K120513 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| | Alma Lasers, Ltd. | | Syneron Medical | EndyMed |
| | Family of Accent RF Pixel Tips with
PixelRF Module/ Handpiece | Alma Lasers Family of
Accent RF Systems
[Accent, Accent XL,
Accent Elite] (w/ UniPolar
& BiPolar Handpieces] | Matrix RF Applicator | RF applicator |
| Characteris
tic | | | | |
| RF Power
(or Energy) | • UniPolar
- Recommended Range -
Stationary Tips
45-60 W | | • Bipolar - Up to 25 Joules
per cm² | • Bipolar up to 65 watts |
| | - Recommended Range - Roller
Tips
35-55 W | • UniPolar & UniLarge
Up to 200 W (1.51 W/mm²)
(Nominal 120-140 W) | (Tunable SelectPulse™
fractional technology – 3
programs which emulate the
tissue effects of common
skin resurfacing fractional
laser technologies) | Up to 62mj/pin |
| | - Maximum for Accent System
Up to 200 W (2.08 W/mm²)
(Nominal 35-80 W - PixelRF Tips –
range of 0.15 to 2.08 W/mm²) | • BiPolar & BiFolarS
Up to 420 W (1.51 W/mm²)
(Nominal 250-290 W) | | |
..
.. •
'
Premarket Notification, Special 510(k) Submission for
Alma Lasers Accent Pixel® Tips
:
Section 5: Page 5
.
p.
a
e
5
K 121150
ర్ P 9
્રિ
5
| 0XXXX | K072699, K07000 K101147 | 073572, K09002 | 083461, K101510, K12051 | |
|---|---|---|---|---|
| Alma Lasers, Ltd | yneron Medic | indyMed | ||
| amily of Accent RF Pixel Tips with | ||||
| PixelRF Module/ Handpiece | lma Lasers Family of ccent RF Systems | latrix RF Applicator | . **************************************************************************************************************************************************************************** | |
| RF applicator | ||||
| Accent, Accent XL, Accent Elite] (w/ UniPol & BiPolar Handpieces] | ||||
| Characteri | ||||
| tic | ||||
| Tip Matrix | Stationary PixelRF Tips | ot applicab | 2 matrix spo | |
| · ~ 110 Pixel points (1.0 pixels/mm²) | . . | 64 Matrix Points – per pulse | (1.3 matrix spots/mm | |
| K072699 & K070004 | ||||
| oller PixelRF Tips | 0.4 points/mr | |||
| ~132 Pixel points per cm | ||||
| (1.3 pixels/mm² | ||||
| Treatment Stationary. PixelRF Tips (Unipolar) . | UniPolar & UniLarg | 10.x 15.mm | ||
| Area | 12 mm dia | 13 to 19 mm dia | x 12 mm — disposable | |
| • Roller PixelRF Tips (Unipolar) | BiPolarS & BiPola | spot' size (unipola | ||
| 10 x 22.7 mm circumference 'roller' | 95 to 13 mm dia | |||
| landpiece | Pixel - Handpiece - 160 x 155 mm | UniPolar - 169 x 205 mm | 5.9 x 6.3 inches (15 | Inknowi |
| Dimensions | BiPolar - 167 x 203 mm | cm) | ||
| Premarket Notification, Special 510(k) Submission for Alma Lasers Accent Pixel® Tips | ection 5: Page |
・・・・・・・・ . .
KI 21150
Page 6 of 8
6
| 0XXX | K072699, K07000 K101147 | 073572, K09002 | 083461, K101510, K1205 | |
|---|---|---|---|---|
| lma Lasers, Ltd | neron Medic | EndyMed | ||
| amily of Accent RF Pixel Tips wit ixel8f Module/ Handpiece | ma Lasers Family of cent RF Systems cent RF Systems cent RF Systems cent Elited (w/1L) (Lift (Lift) BiPolar Handy (w/10ces) | atrix RF Applicator | RF applicato: | |
| Character | ||||
| tice | ||||
| Patient | tationary Pixel Tips – Aluminum | andpiece | nknow | nknow |
| Materials | ||||
| Contac | Roller Pixel®F Tips – Aluminum, | |||
| Sapphire | nodized aluminum ar | |||
| elrin plastic | : | |||
| : | ||||
| provideo | ||||
| How | sposable and Reusable Stationary Roller Pixel® Tips: | ot applicab | sposable tip – up to | |
| pulses | isposable tip - up to | |||
| oulses | ||||
| ble Tips | ||||
| lable | ||||
| Reusable, cleanable, steriliza | ||||
| nd disposable tips also avail | ||||
| Electrical | ||||
| Reqs | . …, | |||
| 10-120 V; 50-60 Hz; 5 | 0-120 V, 50-60 Hz, 5 | 0 - 230 VAC, 50-60 Hz, | ||
| 7.5A | 0-230 VAC, 1-3 A, 5 | |||
| Hz | ||||
| System Dimensions | ||||
| (;;) | 6 x 17 x 16 AccentXL; 21 x 17 x 38 ccent; 26 x 18 x 16 Accent Beauty | 6 x 17 x 16 Accent) | ||
| l x 17 x 38 Acce | .87 x 15.35 x 11 abletop system) | 15 x 30 x 19 cm; 45 x | ||
| in. | ||||
| System Weight | 10(XL) | ર Pas | ||
| S | 4 lbs (7 k | 3 kg; 72.5 |
.
Section 5: Page 7
Premarket Notification, Special 510(k) Submission for:
Alma Lasers Accent Pixel® Tips
2 || K 1 50
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ge 7 of 8
7
Safety and Effectiveness Information VII.
The review of the indications for use and technical characteristics provided demonstrates that the Accent Pixel RF Tips are substantially equivalent to the predicate devices. Additionally, animal and human clinical data were submitted to substantiate performance.
0
VIII. Conclusion
The Accent Pixel RF Tips were found to be substantially equivalent to the predicate devices.
The Accent Pixel RF Tips share the identical indications for use, similar design features, and functional features with, and thus are substantially equivalent to, the predicate devices.
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alma Lasers Incorporated % Ms. Kathy Maynor Regulatory Consultant 485 Half Day Road, Suite W No. 100 Buffalo Grove, Illinois 60089
Re: K121150
Trade/Device Name: Pixel RF Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accesories Regulatory Class: Class II Product Code: GEI Dated: August 31, 2012 Received: September 11, 2012
Dear Ms. Maynor:
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. Iisting 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 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
SEP 21 2012
9
Page 2 - Ms. Kathy Maynor
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/ucm11.5809.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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Page 1 of 2
Indications for Use Statement
510(k) Number (if known): KAB
K 121150
Device Name: Pixel RF Tips
Indications for Use:
Intended Use
The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.
Indications for Use
The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Nilke. Sgle. for nxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Prescription Use . V
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Premarket Notification, Special 510(k) Submission for: Alma Lasers Accent Pixel® Tips
11
K121150
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Premarket Notification, Special 510(k) Submission for:
Alma Lasers Accent Pixel® Tips
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