-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.

Device Description

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

1. The main console unit
1. Footswitch.
1. Accessories

AI/ML Overview

This is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive performance studies with acceptance criteria in the way a de novo or PMA submission would. Therefore, the document does not contain the detailed performance study information requested for an AI/ML device.

Here's an analysis based on the provided text, highlighting what is and isn't available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or specific accuracy metrics from a study. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to the predicate device by matching technical characteristics and indications for use.

The tables in sections 8-VI (Tables 1, 2, and 3) compare the "Alma Diode Tabletop Laser" (K13) to the "Quanta Diode Laser Family" (K100558) across several technical parameters. The "reported device performance" in this context is the Alma device meeting these technical specifications and having similar indications for use.

Parameter	Alma Diode Tabletop Laser (K13) (Reported Performance - Matches Predicate)	Predicate Device (K100558) (Implicit Acceptance Criteria)
Product Code & Regulation No.	GEX, 21 CFR 878.4810	GEX, 21 CFR 878.4810
Laser Wavelength [nm] (1470nm module)	1470	1470
Max power (1470nm module)	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 (1470nm module)	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 (1470nm module)	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 (1470nm)	Endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux; laser assisted lipolysis.	Endovenous occlusion of the greater saphenous vein in Patients with Superficial Vein Reflux; laser assisted lipolysis.

Similar tables exist for the 980nm and 810nm modules, with minor differences in wavelength, max power (30W for 980nm/810nm), and aiming beam wavelength (635nm vs 650nm for predicate).

The study that proves the device meets the acceptance criteria:

The "study" cited is the comparison to predicate devices and adherence to recognized electrical and laser safety standards. There are no clinical performance studies, accuracy metrics, or AI/ML specific evaluations described in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) for a laser device, not an AI/ML diagnostic. There are no test sets of patient data mentioned for performance evaluation. The device was tested to meet specific safety and electrical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information is not relevant to this 510(k) submission, which focuses on substantial equivalence of a physical laser device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI/ML product designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this submission is implicitly the established safety and performance profile of the predicate device and adherence to international electrical and laser safety standards.

The device 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

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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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
1. Footswitch.
1. Accessories

V. Indications for Use

The Alma diode tabletop laser is intended for use in dermatologic and general surgical procedures.

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VI. Summary of Technical Characteristics

	K13	K100558
	Alma diode tabletop laser	Quanta Diode Laser Family
Parameter
Product Code &Regulation No.	GEX21 CFR 878.4810	GEX21 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

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Table 2: Salient Characteristics of the 980nm module and the Predicate Devices

・

	K13	K100558
	Alma diode tabletop laser	Quanta Diode Laser Family
Parameter
ProductCode &RegulationNo.	GEX21 CFR 878.4810	GEX21 CFR 878.4810
LaserWavelength[nm]	980nm	980nm
Max power	30W	30W
Light/LaserSource	Diode	Diode
LaserDelivery	Optical Fiber	Optical Fiber
OperationMode	Continuous wave, singlepulse, pulsed	Continuous wave, single pulse,pulsed
PulseDuration	10-990ms	3ms - 2.5s
Bare fibersize	200, 300, 320, 400, 600, 800,1000	200, 300, 320, 400, 600, 800,1000
UserInterface	LCD touch screen	LCD touch screen
Aiming beam	635nm	650nm
ElectricalRequirements	100-240, V AC 50-60 Hz, 6.3A,	100-240, V AC 50-60 Hz, 6.3 A.single phase.
Indicationsfor Use	The Alma 980nm diodetabletop laser is indicatedfor use in endovenousocclusion of the greatersaphenous vein in patientswith superficial veinreflux. The Alma 980nmdiode tabletop laser isfurther indicated for laserassisted lipolysis,	The QUANTA Diode LaserSystem is intended for delivery oflaser light to soft tissue in thecontact and non contact modeduring surgical proceduresincludingvia endoscopes. The QUANTADiode Laser System is generallyindicated for use in endovenousocclusion of the greatersaphenous vein in Patients withSuperficial Vein Reflux. TheQUANTA980 DiodeLaser is further indicated for laserassisted lipolysis. (This is asubset of the cleared indicationsfor this product)

・

: 3/5

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Table 3: Salient Characteristics of 810nm diode module and the predicate devices

વે

	K13	K100558
	Alma diode tabletop laser	Quanta Diode Laser Family
Parameter
ProductCode &RegulationNo.	GEX21 CFR 878.4810	GEX21 CFR 878.4810
LaserWavelength[nm]	810nm	808nm
Max power	30W	30W
Light/LaserSource	Diode	Diode
LaserDelivery	Optical Fiber	Optical Fiber
OperationMode	Continuous wave, singlepulse, pulsed	Continuous wave, single pulse,pulsed
PulseDuration	10-990ms	3ms - 2.5s
Bare fibersize	200, 300, 320, 400, 600, 800,1000	200, 300, 320, 400, 600, 800,1000
UserInterface	LCD touch screen	LCD touch screen
Aiming beam	635nm	650nm
ElectricalRequirements	100-240, V AC 50-60 Hz, 6.3A.	100-240, V AC 50-60 Hz, 6.3 A,single phase,
Indicationsfor Use	The Alma 810nm diodetabletop laser is indicatedfor endoluminal orendovenous laser surgeryfor saphenous incompetentveins.	The QUANTA Diode LaserSystem is intended for delivery oflaser light to soft tissue in thecontact and non contact modeduring surgical proceduresincludingvia endoscopes. The QUANTA808 Diode Laser System isgenerally indicated forendoluminal or endovenous lasersurgery for saphenousincompetent veins. (This is asubset of the cleared indicationsfor this product).

4 / 5

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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.

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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

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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 indications for use for the 1470nm Alma Diode Tabletop Laser include:

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″

Regulation Number and Section

§ 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.