Who is the manufacturer of ALMA LASERS FAMILY OF PIXEL RF TIPS?

Alma Lasers, Inc. filed the 510(k) submission for ALMA LASERS FAMILY OF PIXEL RF TIPS (K121150).

What is the FDA product code for ALMA LASERS FAMILY OF PIXEL RF TIPS?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ALMA LASERS FAMILY OF PIXEL RF TIPS?

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

Who can help prepare an FDA 510(k) submission like ALMA LASERS FAMILY OF PIXEL RF TIPS?

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.

ALMA LASERS FAMILY OF PIXEL RF TIPS

K121150 · Alma Lasers, Inc. · GEI · Sep 21, 2012 · General, Plastic Surgery

Device Facts

Record ID	K121150
Device Name	ALMA LASERS FAMILY OF PIXEL RF TIPS
Applicant	Alma Lasers, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Sep 21, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures. 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.

Device Story

Accent Pixel RF Tips are radiofrequency (RF) energy delivery accessories for the Alma Lasers Accent RF system. Tips are available in stationary and roller configurations; constructed from aluminum and sapphire. Device functions by delivering unipolar RF energy to skin tissue to induce ablation and resurfacing. Used in clinical settings by healthcare professionals. Output is thermal energy applied to the skin surface; clinical effect is tissue ablation and resurfacing for wrinkle reduction. Benefits include non-invasive skin rejuvenation. System operates via connection to the Accent RF console; energy parameters are controlled by the clinician.

Clinical Evidence

Performance substantiated by animal histology data and human clinical data. No specific quantitative metrics (e.g., p-values, sensitivity) provided in the summary.

Technological Characteristics

RF energy delivery accessory; stationary and roller tip configurations. Materials: aluminum and sapphire. Stationary tip: ~110 points (1.0 pixels/mm²). Roller tip: ~132 points/cm (1.3 pixels/mm²). Energy source: Unipolar RF from Accent system console. Sterilization: cleanable/sterilizable (reusable) or disposable options.

Indications for Use

Indicated for patients requiring dermatological procedures for skin ablation and resurfacing, and for the non-invasive treatment of wrinkles and rhytids when used with the unipolar handpiece.

Regulatory Classification

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.

Predicate Devices

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)

Submission Summary (Full Text)

{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 . . : : . . ' . ・ + -: : · . . " Concurrence of CDRH, Office of Device Evaluation (ODE) ・ . . Page . . : . " . . Premarket Notification, Special 510(k) Submission for: Alma Lasers Accent Pixel® Tips l in of th י ್ನಿ e · ('ম --- i

ALMA LASERS FAMILY OF PIXEL RF TIPS

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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ALMA LASERS FAMILY OF PIXEL RF TIPS

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Device Story

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Identification

Predicate Devices

Submission Summary (Full Text)

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