Who is the manufacturer of ALMA DIODE TABLETOP LASER?

Alma Lasers , Ltd. filed the 510(k) submission for ALMA DIODE TABLETOP LASER (K140005).

What is the FDA product code for ALMA DIODE TABLETOP LASER?

GEX. 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 ALMA DIODE TABLETOP LASER?

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

What are the predicate devices for ALMA DIODE TABLETOP LASER?

Quanta Diode Laser Family (K100058).

Who can help prepare an FDA 510(k) submission like ALMA DIODE TABLETOP LASER?

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 DIODE TABLETOP LASER

K140005 · Alma Lasers , Ltd. · GEX · Jul 18, 2014 · General, Plastic Surgery

Device Facts

Record ID	K140005
Device Name	ALMA DIODE TABLETOP LASER
Applicant	Alma Lasers , Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Jul 18, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.

Device Story

The Alma Diode Tabletop Laser is a surgical laser system consisting of a main console, footswitch, and accessories. It utilizes diode laser modules at 810nm, 980nm, or 1470nm wavelengths to deliver laser energy to soft tissue via optical fibers. The device operates in continuous wave, single pulse, or pulsed modes. It is intended for use by clinicians in dermatologic and general surgical settings. The operator controls the device via an LCD touch screen interface. The laser energy is used for endovenous occlusion of the greater saphenous vein and laser-assisted lipolysis. By delivering controlled thermal energy to target tissues, the device facilitates surgical procedures, potentially benefiting patients through minimally invasive vein treatment and lipolysis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60601-2-22, IEC 60825-1).

Technological Characteristics

Diode laser source; wavelengths 810nm, 980nm, 1470nm; max power 15W-30W; optical fiber delivery; continuous/pulsed operation; LCD touch screen interface; 635nm aiming beam; 100-240V AC power; compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for endovenous laser surgery for saphenous incompetent veins (810nm module); endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser assisted lipolysis (980nm and 1470nm modules).

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

Quanta Diode Laser Family (K100058)

Related Devices

K160952 — Alma Diode Tabletop Laser · Alma, Ltd. · May 5, 2016
K112253 — CERALAS 147NM DIODE LASER SYSTEM · Biolitec, Inc. · Sep 20, 2011
K080104 — VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542 · Vascular Solutions, Inc. · Mar 26, 2008
K240179 — Medical Diode Laser (Model: L2) · Wuhan Pioon Technology Co., Ltd. · Mar 21, 2024
K090164 — CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER · Biolitec, Inc. · Jun 26, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ # JUL 1 8 2014 ## K140005 ### Section 8 - 510(k) Summary or 510(k) Statement #### l, General Information Submitter: Alma Lasers, Ltd, Halamish St. POB 3021 Caesarea Industrial Park, Caesarea, Israel 38900 Contact Person: Kathy Maynor Consultant 352-586-3113 (cell) Summary Preparation Date: Dec 30, 2013 - II. Names | Device Names: | The Alma Diode Tabletop Laser | |----------------------|-------------------------------| |----------------------|-------------------------------| Surgical Powered Light Instrument, Primary Classification Names: ### III. Predicate Devices . Predicate Device ___________________________________________________________________________________________________________________________________________________________ K # ** K100058 Quanta Diode Laser Family ### IV. Product Description The Alma Diode Tabletop Laser is comprised of the following major components: - 1. The main console unit - 2. Footswitch. - 3. Accessories ### V. Indications for Use The Alma diode tabletop laser is intended for use in dermatologic and general surgical procedures. {1}------------------------------------------------ ### VI. Summary of Technical Characteristics . | | K13 | K100558 | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Alma diode tabletop laser | Quanta Diode Laser Family | | Parameter | | | | Product Code & Regulation No. | GEX 21 CFR 878.4810 | GEX 21 CFR 878.4810 | | Laser Wavelength [nm] | 1470 | 1470 | | Max power | 15W | 15W | | Light/Laser Source | Diode | Diode | | Laser Delivery | Optical Fiber | Optical Fiber | | Operation Mode | Continuous wave, single pulse, pulsed | Continuous wave, single pulse, pulsed | | Pulse Duration | 10-990ms | 3ms - 2.5s | | Bare fiber size | 200, 300, 320, 400, 600, 800, 1000 | 200, 300, 320, 400, 600, 800, 1000 | | User Interface | LCD touch screen | LCD touch screen | | Aiming beam | 635nm | 650nm | | Electrical Requirements | 100-240. V AC 50-60 Hz, 6.3 A | 100-240, V AC 50-60 Hz, 6.3 A, single phase, | | Indications for Use | The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis, | The QUANTA Diode Laser System is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The QUANTA Diode Laser System is generally indicated for use in endovenous occlusion of the greater saphenous vein in Patients with Superficial Vein Reflux. The QUANTA1470 Diode Laser is further indicated for laser assisted lipolysis | . . . Table 1: Salient Characteristics of the 1470nm module and the Predicate Devices · : : 2/5 י : {2}------------------------------------------------ # Table 2: Salient Characteristics of the 980nm module and the Predicate Devices ・ | | K13 | K100558 | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Alma diode tabletop laser | Quanta Diode Laser Family | | Parameter | | | | Product Code & Regulation No. | GEX 21 CFR 878.4810 | GEX 21 CFR 878.4810 | | Laser Wavelength [nm] | 980nm | 980nm | | Max power | 30W | 30W | | Light/Laser Source | Diode | Diode | | Laser Delivery | Optical Fiber | Optical Fiber | | Operation Mode | Continuous wave, single pulse, pulsed | Continuous wave, single pulse, pulsed | | Pulse Duration | 10-990ms | 3ms - 2.5s | | Bare fiber size | 200, 300, 320, 400, 600, 800, 1000 | 200, 300, 320, 400, 600, 800, 1000 | | User Interface | LCD touch screen | LCD touch screen | | Aiming beam | 635nm | 650nm | | Electrical Requirements | 100-240, V AC 50-60 Hz, 6.3 A, | 100-240, V AC 50-60 Hz, 6.3 A. single phase. | | Indications for Use | The Alma 980nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980nm diode tabletop laser is further indicated for laser assisted lipolysis, | The QUANTA Diode Laser System is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The QUANTA Diode Laser System is generally indicated for use in endovenous occlusion of the greater saphenous vein in Patients with Superficial Vein Reflux. The QUANTA980 Diode Laser is further indicated for laser assisted lipolysis. (This is a subset of the cleared indications for this product) | · ・ . : 3/5 · {3}------------------------------------------------ # Table 3: Salient Characteristics of 810nm diode module and the predicate devices · વે | | K13 | K100558 | |----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Alma diode tabletop laser | Quanta Diode Laser Family | | Parameter | | | | Product Code & Regulation No. | GEX 21 CFR 878.4810 | GEX 21 CFR 878.4810 | | Laser Wavelength [nm] | 810nm | 808nm | | Max power | 30W | 30W | | Light/Laser Source | Diode | Diode | | Laser Delivery | Optical Fiber | Optical Fiber | | Operation Mode | Continuous wave, single pulse, pulsed | Continuous wave, single pulse, pulsed | | Pulse Duration | 10-990ms | 3ms - 2.5s | | Bare fiber size | 200, 300, 320, 400, 600, 800, 1000 | 200, 300, 320, 400, 600, 800, 1000 | | User Interface | LCD touch screen | LCD touch screen | | Aiming beam | 635nm | 650nm | | Electrical Requirements | 100-240, V AC 50-60 Hz, 6.3 A. | 100-240, V AC 50-60 Hz, 6.3 A, single phase, | | Indications for Use | The Alma 810nm diode tabletop laser is indicated for endoluminal or endovenous laser surgery for saphenous incompetent veins. | The QUANTA Diode Laser System is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The QUANTA 808 Diode Laser System is generally indicated for endoluminal or endovenous laser surgery for saphenous incompetent veins. (This is a subset of the cleared indications for this product). | · . 4 / 5 {4}------------------------------------------------ #### VII. Safety and Effectiveness Information The review of the indications for use and technical characteristics provided demonstrates that the Alma diode tabletop laser is substantially equivalent to the predicate devices. The Diode Tabletop Laser was tested by a certified laboratory according to: IEC 60601-1: 1988+A1:1991+A2:1995: Medical Electrical Equipment Part 1: General Requirements for basic safety and essential performance IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for safety-Collateral Standard: Electromagnetic compatibility - Requirements and tests (2001 + A1(4)) IEC 60601-2-22:1995 Medical electrical equipment- Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment 1995. IEC 60825-1:2007 (2nd edition) Safety of Laser Products-Part 1: Equipment Classification and Requirements ### Conclusion VIII. The Alma diode tabletop laser was found to be substantially equivalent to the predicate devices. The Alma diode tabletop laser shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 18, 2014 Alma Lasers Ltd. % Ms. Kathy Maynor Regulatory Consultant for Alma LTD 26 Rebecca Court Homosassa. Florida 34446 Re: K140005 Trade/Device Name: The Alma Diode Tabletop Laser 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: GEX Dated: April 29, 2014 Received: June 20, 2014 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, 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 that I DA has intatutes and regulations administered by other Federal agencies. You must or any reath 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 {6}------------------------------------------------ Page 2 - Ms. Kathy Maynor 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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, # David Krause -S - Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. | 510(k) Number (if known) | K140005 | |--------------------------|---------| |--------------------------|---------| Device Name The Alma Diode Tabletop Laser Indications for Use (Describe) Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures. Indications for Use The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules: The indications for use for the 810nm Alma Diode Tabletop Laser include: - The Alma 810nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins. The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980nm diode tabletop laser is further indicated for laser assisted lipolysis. The indications for use for the 1470nm Alma Diode Tabletop Laser include: -The Alma 1470nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470nm diode tabletop laser is further indicated for laser assisted lipolysis. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Neil R Ogden -S 2014.07.17 16:13:51 -04′00″