Alma Diode Tabletop Laser

K160952 · Alma, Ltd. · GEX · May 5, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160952
• Device Name: Alma Diode Tabletop Laser
• Applicant: Alma, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 5, 2016
• Decision: SESE
• Submission Type: Special
• 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 used in dermatologic and general surgical procedures. It utilizes diode laser modules (810 nm, 980 nm, or 1470 nm) to deliver laser energy to soft tissue via optical fibers. The system includes a main console, footswitch, and an automatic pull-back accessory. The pull-back accessory controls the rate of fiber movement along the vein wall during endovenous procedures, ensuring consistent energy delivery and minimizing treatment time. The device is operated by clinicians in a clinical setting. The clinician uses an LCD touch screen to configure parameters and monitor the procedure. By automating the fiber withdrawal, the device provides consistent exposure, which can improve procedural efficiency and potentially benefit the patient by ensuring uniform vein occlusion.

Clinical Evidence

Bench testing only. Verification testing confirmed mechanical pull-back speeds matched requested settings. Software was verified and validated per IEC 62304 and FDA guidance. No clinical data presented.

Technological Characteristics

Diode laser source; wavelengths 810nm, 980nm, 1470nm; optical fiber delivery; LCD touch screen interface; 100-240V AC power. Pull-back accessory provides automatic fiber movement at 1, 2, and 4 mm/sec. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 62304 (software).

Indications for Use

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

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

• ALMA DIODE TABLETOP LASER (K140005)
• DIOTECH CO LTD - ATOVEN (K133774)

Reference Devices

• Quanta Diode Laser Family (K100558)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized graphic of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The overall design is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 5, 2016

Alma Ltd % Ms. Kathy Maynor Regulatory Consultant 26 Rebecca Ct Homosassa, Florida 34446

Re: K160952

Trade/Device Name: 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 1, 2016 Received: April 5, 2016

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 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

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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 [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160952 "

Device Name 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

laser assisted lipolysis.

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 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm 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 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.

The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for

Type of Use (Select one or both, as applicable)

[X] 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)

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## Section 8 – 510(k) Summary or 510(k) Statement

#### I. General Information

| Submitter: | Alma Lasers, Ltd,<br>Halamish St. POB 30<br>Industrial Park<br>Caesarea Israel 38900 |
|---------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Kathy Maynor<br>Consultant<br>352-586-3113 (cell) |
| Summary Preparation Date: | May 4, 2016 |

#### II. Names

| Device Names: | Alma Diode Tabletop Laser |
|-------------------------------|-----------------------------------|
| Primary Classification Names: | Surgical Powered Light Instrument |

#### III. Predicate Devices

| K # | Predicate Device |
|---------|---------------------------|
| K140005 | ALMA DIODE TABLETOP LASER |
| K133774 | DIOTECH CO LTD - ATOVEN |

#### IV. Product Description

The Alma Diode Tabletop Laser is comprised of the following major components:

- The main console unit 1.
- 2. Pull-back
- 3. Footswitch
- Accessories 4.

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#### V. Indications for Use

### 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 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm 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 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.

The indications for use for the 147 0nm Alma Diode Tabletop Laser include:

-The Alma 1470 mm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.

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#### VI. Summary of Technical Characteristics

Table 1: Salient Characteristics of the 1470nm module and the Predicate Devices

| | K13<br>Alma diode tabletop laser | K100558<br>Quanta Diode Laser Family |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | | |
| Product<br>Code &<br>Regulation<br>No. | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 |
| Laser<br>Wavelength<br>[nm] | 1470 | 1470 |
| Max power | 15W | 15W |
| Light/Laser<br>Source | Diode | Diode |
| Laser<br>Delivery | Optical Fiber | Optical Fiber |
| Operation<br>Mode | Continuous wave, single<br>pulse, pulsed | Continuous wave, single pulse,<br>pulsed |
| Pulse<br>Duration | 10-990ms | 3ms - 2.5s |
| Bare fiber<br>size | 200, 300, 320, 400, 600,<br>800, 1000 | 200, 300, 320, 400, 600, 800,<br>1000 |
| User<br>Interface | LCD touch screen | LCD touch screen |
| Aiming beam | 635nm | 650nm |
| Electrical<br>Requirements | 100-240, V AC 50-60 Hz,<br>6.3 A, | 100-240, V AC 50-60 Hz, 6.3<br>A, single phase, |
| Indications<br>for Use | The Alma 1470nm diode<br>tabletop laser is indicated<br>for use in endovenous<br>occlusion of the greater<br>saphenous vein in<br>patients with superficial<br>vein reflux. The Alma<br>1470nm diode tabletop<br>laser is further indicated<br>for laser assisted<br>lipolysis, | The QUANTA Diode Laser<br>System is intended for delivery<br>of laser light to soft tissue in the<br>contact and non contact mode<br>during surgical procedures<br>including<br>via endoscopes. The QUANTA<br>Diode Laser System is generally<br>indicated for use in endovenous<br>occlusion of the greater<br>saphenous vein in Patients with<br>Superficial Vein Reflux. The<br>QUANTA1470 Diode<br>Laser is further indicated for<br>laser assisted lipolysis |

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| Manufacturer | Alma Lasers LTD | Alma Lasers LTD | DIOTECH CO LTD |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cleared Device | KXXXXXX | K140005 | K133774 |
| System Platform | Alma Diode Tabletop Laser | Alma Diode Tabletop Laser | ATOVEN |
| Accessory Description | Alma Lasers Pull-Back<br>Device | | Automatic fiber pull-<br>back driver ATOVEN |
| Wavelength<br>Supported | 1470nm | 810nm, 980nm, and<br>1470nm | 1470nm |
| Intended Use /<br>Indications For Use | The Alma Lasers Pull-Back<br>Device is an accessory<br>intended for use in<br>conjunction with the<br>previously cleared Alma<br>Diode Tabletop Laser<br>1470nm (K140005).<br>The Alma Diode Tabletop<br>Laser 1470 nm (K140005) is<br>intended for use in<br>dermatologic and general<br>surgical procedures:<br>endovenous occlusion of<br>the greater saphenous vein<br>in patients with superficial<br>vein reflux, and for laser<br>assisted lipolysis. | The Alma Diode Tabletop<br>Laser 1470 nm is intended<br>for use in dermatologic and<br>general surgical<br>procedures: endovenous<br>occlusion of the greater<br>saphenous vein in patients<br>with superficial vein reflux,<br>and for laser assisted<br>lipolysis. | ATOVEN is a diode<br>laser system<br>designed to delivery<br>of laser light to soft<br>tissue during general<br>surgery procedures.<br>This device intended<br>for treatment of reflux<br>of the saphenous<br>veins of thigh<br>associated with<br>varicose veins and<br>varicosities. |
| Pullback Accessory | | | |
| Dimensions (cm)<br>(H x W x D) | 5x20x8 | NA | Unk. |
| Weight (kg) | ~0.5 | NA | Unk. |
| Pullback Speed<br>(mm/sec) | 4 Steps:<br>1, 2, and 4 mm/sec | NA | 6 Steps:<br>0.5, 0.7, 1.0, 1.2, 1.5,<br>and 2.0 mm/sec |
| Pullback mode | Automatic | NA | Automatic |
| Acceptable fiber sizes | 400µm fiber<br>600µm fiber | NA | 400µm fiber<br>600µm fiber |
| Mode of Action | Controls the rate of fiber<br>movement along the vein<br>wall providing consistent<br>exposure and minimizing<br>treatment time. | NA | Controls the rate of<br>fiber movement along<br>the vein wall<br>providing consistent<br>exposure and<br>minimizing treatment<br>time. |

#### Safety and Effectiveness Information VII.

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. Additional product electrical safety testing and EMC testing was successfully completed in accordance with the following standards:

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- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety ●
- . IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances -Requirements and tests

## VIII. D Design Verification Testing

Design verification testing was performed for the Alma 1470mm diode tabletop laser with the pullback accessory. The testing consisted of performing mechanical tests to verify the actual pull back speeds matched the requested speeds.

Additionally, the software controlling the Alma 1470nm diode tabletop laser with the pull-back accessory was fully verified and validated in accordance with IEC 62304 and the FDA guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

#### IX. Conclusion

The Alma diode tabletop laser with the pull-back accessory was found to be substantially equivalent to the predicate device.

The Alma diode tabletop laser with the pull-back accessory shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.