The Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are intended for use in surgical applications requiring the ablation, vaporization, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

HyLight-CO2

The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery

The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

laser skin resurfacing
laser derm-abrasion
laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.

Pixel

The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing.

ProScan

The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:

· Laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for:

· Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Device Description

The Alma Hybrid Laser System consists of:

Laser system console (containing the optical bench assembly and laser, the ● microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
LCD control panel with touch-screen technology: the LCD display provides information . on the status and settings of the The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system.
Two wavelengths – CO2 and 1570 nm
. Articulated arm
Footswitch
Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator) ●

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the Alma Hybrid Laser System. Within this document, the main objective is to demonstrate substantial equivalence to predicate devices, rather than establishing new efficacy or safety criteria for the device itself. Therefore, it does not contain a typical "acceptance criteria" table for device performance against specific metrics, nor does it detail a clinical study designed to prove the device meets such criteria in the way one might expect for a novel device.

However, based on the document, we can infer some "acceptance criteria" through the comparisons made with predicate devices and the performance testing conducted. The study described focuses on histology testing on porcine animals to justify technical differences in some applicators.

Here's an attempt to extract and frame the information requested, with the understanding that the document's purpose is a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria for efficacy in humans are not provided (as it's a substantial equivalence claim), the "acceptance criteria" are implied by demonstrating similar technical characteristics to the predicate devices and confirming tissue effects in an animal model meet expected physiological responses.

Acceptance Criteria (Implied)	Reported Device Performance (Alma Hybrid Laser System)
Technical Equivalence to Predicate Devices:
- Wavelengths	- HyLight CO2 & Pixel CO2: 10600 nm (Same as predicate)
	- ProScan 1570nm: 1570 nm (Close to predicate's 1565 nm)
- Output Power/Energy	- HyLight CO2: 30W, 70W (Same as predicate)
	- Pixel CO2: 5mJ/Pixel - 150 mJ/Pixel (Same as predicate)
	- ProScan CO2: Up to 1000 mJ (Predicate) vs 120 (30W model)/240 mJ (70W model) (The document states "Output energy" vs "Up to 1000 mJ" for predicate. It also later clarifies "max energy output is within the range of the predicate device" for Pixel CO2, and for ProScan CO2, differences in spot size, beam density and pulse duration are noted, with histology supporting these differences.)
	- ProScan 1570nm: 24mJ-144 mJ/pixel (Predicate: 10 mJ per beam – 70 mJ per beam. Hybrid system has different range, but is considered substantially equivalent.)
- Spot Size, Repetition Rate, Pulse Duration, Fluence, Beam Density	Differences noted for some applicators, but documented as being within acceptable ranges or justified by performance testing (e.g., histology). For HyLight-CO2, spot size, pulse duration, and output energy differ, but fluence is within predicate range. For Pixel CO2, pulse duration differs but max energy output is within predicate range. For ProScan, differences in spot size, beam density, and pulse duration are noted.
Safety and Performance Standards Compliance:	- Complied with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-1, ISO 17665-1, IEC 62304, ISO 14971.
Expected Histological Tissue Response (for ProScan Applicator):	- Histology results complied with FDA requirements at 0, 3, 7, and 14 days.
	- Re-epithelialization observed three days after radiation in all specimens.
	- No adverse events or unexpected complications in the swines.
Device Functionality:	- Functioned as intended and results observed were as expected.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Histology Study): 3 Domestic female (Mixed Landrace & Large White) crossbred swine.
Data Provenance: The study was implicitly prospective for the animal testing, conducted by Alma Lasers. The document does not specify the country of origin of the data beyond "Alma also performed histology testing on porcine animals."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for evaluating the histology results. It states, "histology results complied with the FDA requirements." This implies interpretation by qualified individuals, but no details are given.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the animal histology results. It simply states that the "histology results complied with the FDA requirements" and "Re-epithelialization was observed three days after radiation in all specimens." This suggests a direct evaluation against predefined criteria rather than a consensus process among multiple independent reviewers.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no human clinical studies were deemed needed to support this submission." The study described is an animal histology study, not a human reader study.

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

This question is not applicable. The device is a laser system, not an AI or algorithm-based diagnostic tool. The performance described relates to the physical and biological effects of the laser, not a computational algorithm's performance.

7. The Type of Ground Truth Used

For the animal study, the ground truth was histology from punch biopsies taken from the radiated points at 0, 3, 7, and 14 days, examined for re-epithelialization and other tissue effects.

8. The Sample Size for the Training Set

This question is not applicable in the context of this 510(k) submission. The device is a physical laser system, not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as point 8.

Summary

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July 2, 2021

Alma Lasers, Ltd. Avi Hirshnzon Evp RAqa 18 Haharash Street, North Industrial Park Caesarea Ha Zafon, 3079895 Israel

Re: K203441

Trade/Device Name: The Alma Hybrid Laser System 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, ONG Dated: November 20, 2020 Received: November 23, 2020

Dear Avi Hirshnzon:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203441

Device Name The Alma Hybrid Laser System

Indications for Use (Describe)

HyLight-CO2

The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery

The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

- laser skin resurfacing
- laser derm-abrasion
- laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.

Pixel

ProScan

The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:

· Laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for:

· Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K203441 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

Owner Name	Alma Lasers Inc.
Address	18 Haharash StreetNORTH INDUSTRIAL PARKCAESAREA, IL 3079895
Contact Person	Kathy MaynorRegulatory ConsultantEmail : regulatory@almalasers.comPhone: 352-586-3113 (cell)Facsimile: 646-805-1305Secondary contact: Jessica Rivera-MontejoAssoc. Director of RegulatoryEmail: regulatory@almalasers.comPhone: 224-377-2019Facsimile: 646-805-1305
Summary Preparation Date	July 2, 2021

Submitter Information [21 CFR 807.92(a) (1)] I.

II. Name of device [21 CFR 807.92 (a) (2)]

Trade or Proprietary Name	The Alma Hybrid Laser System
Common Device Name(s) andRegulatory Class	ProductCode(s)	Classification Panel	Regulation
Electrosurgical cutting andcoagulation device andaccessories Class II	GEX	General & PlasticSurgery Panel, 79(SU)	§ 21 CFR 878.4810
Powered Laser SurgicalInstrument WithMicrobeam/Fractional Output	ONG	General & PlasticSurgery Panel, 79 (SU)	§ 21 CFR 878.4810

III. Predicate Devices [21 CFR 807.92(a) (3)]

Type	510(k) #	Trade Name	Product Code
Primary	K103501	Alma Lasers Pixel CO2 Laser System	GEX
Reference	K080463	Alma Lasers System	GEX
Secondary	K170060	M22 And ResurFx Systems	GEX

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IV. Device Description [21 CFR 807.92(a) (4)]

The Alma Hybrid Laser System consists of:

Laser system console (containing the optical bench assembly and laser, the ● microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
LCD control panel with touch-screen technology: the LCD display provides information . on the status and settings of the The Alma Hybrid Laser System with touch-screen technology provided to input commands into the system.
Two wavelengths – CO2 and 1570 nm
. Articulated arm
Footswitch
Delivery devices (Pixel applicators, Hylight applicators, Proscan applicator) ●

V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]

HyLight-CO2

The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 mm is cleared for use for the particular indications as follows:

Dermatology & Plastic Surgery

The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

- laser skin resurfacing
- laser derm-abrasion
- laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.

Pixel

ProScan

The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: ·Laser skin resurfacing (ablation and/or vaporization) of soft tissue

The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 mm, is indicated for: · Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

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Feature	DeviceAlma Pixel CO2 (K103501)Primary Predicate	Hybrid System (K203441)(Subject Device)
Hylight CO2
Wavelength	10600 nm	Same
Pilot beam	650 nm, 3mW	Same
Spot size (mm)	0.15 dia at 50 mm working distance; 0.2 mm dia. At 100 mm working distance	0.15 - 3.0 at 50 mm working distance0.25- 3.1 (Dia.) at200 mm working distance
Repetition Rate	1-5 Hz	Same
Pulse Duration	1-1000 ms	Same
Repeat Delay	0.01 - 1sec	Same
Min output energy	5 mJ	Same
Output Power	30W, 70W	Same
Fluence	Max 1746 J/mm² for 30W systemMax 3530 J/mm² for the 70W system	Same
CO2 Pixel (7x7 pattern; 9x9 pattern)
Spot Size	0.125 to 0.20 mm dia. pixels in a 10 x10 mm²area (49 pixels) @ 50 mm distance- 0.125 to 0.20 mm dia. pixels in a 11 x 11 mm²area (81 pixels) @ 100 mm distance	Same
Repetition Rate	1-5 Hz	0.5-2Hz
Pulse Duration	100-300 ms for pulsed	1- 405 ms
Energy	5mJ/Pixel - 150 mJ/Pixel	Same
CO2 ProScan
Scanner	Dual axis scanner	Same
Spot size (mm)	0.35 mm@ 100 mm distance	Same
Output energy	Up to 1000 mJ	120 (30W model)/240 mJ (70W model)
Beam density	~5% - 95% untreated tissue between spots	~63% - 97% untreated tissue between spots

VI. Summary of technological characteristics of the device compared to the predicates [21 CFR 807.92(a)(6)]

Device	Lumenis ReSurfxK170060 - Secondary Predicate	Hybrid System (K203441)(Subject Device)
ProScan 1570
Wavelength	1565 nm	1570 nm
Pilot beam	650 nm, <5mW	650 nm, 3mW
Scanner	Dual axis scanner	Same
Tip	cooled	Same
Scan size (mm)	5-18 mm	Up to 30 mm diameter
Output energy	10 mJ per beam – 70 mJ per beam	24mJ-144 mJ/pixel
Beam density	Up to 500 microbeams/cm2	Up to 390 pixels/cm2

The technical characteristics for the Hybrid Laser System are substantially equivalent to the predicate devices. The Alma Hybrid 10600nm non-fractional module, with

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wavelength of 10600 nm have differences in spot size, pulse duration and output energy, but the fluence is within the range of the predicate devices.

The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm have differences in pulse duration, but the max energy output is within the range of the predicate device.

The Alma Hybrid ProScan fractional applicator, with wavelengths of 10600 nm and/or 1570nm wavelengths offers two main treatment modes Monochromatic or Sequential Radiation. the Alma Hybrid ProScan fractional applicator, with wavelengths of 10600 nm, and/or 1570nm Treatment Modes include three fractional patterns - grid, hygrid and grid sequential- with either single or dual wavelengths. The fractional grid patterns are substantially equivalent to their predicate devices with differences in spot size, beam density and pulse duration. Alma did perform histology testing to justify the technical differences.

VII. Performance Testing [21 CFR 807.92(b)(1)]

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 - Electromagnetic Compatibility IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for

basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user's guide

ISO 10993-1 Biological evaluation of medical devices -- Part 1

ISO 17665-1 Sterilization of health care products - moist heat

IEC 62304 Medical Device Software

ISO 14971 Risk Analysis

In addition, software verification and performance validation testing were performed.

Alma also performed histology testing on porcine animals for the ProScan Applicator. Testing was performed safely on the test animals, and the histology results complied with the FDA requirements at 0, 3, 7 and 14 days. Three [3] Domestic female (Mixed Landrace & Large White) crossbred swine were used in this study. During the in-life stage, vital signs, ECG and % saturation were monitored, clinical observations and body weights were monitored and recorded. Re-epithelialization was observed three days after radiation in all specimens. No adverse events or unexpected complications have been detected in the swines. On the last day of trial, biopsies were taken from the center of each radiated point by punch biopsy and were sent to H&E. At the end of the procedure at first, third, and seventh days, the animal was awakened and transferred to the recovery room. Euthanizing of the pigs were done at the end of the study on day 14.

In all instances, the Alma Hybrid Laser System, Delivery Devices and Accessories

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functioned as intended and the results observed were as expected.

VIII. Clinical Data [21 CFR 807.92(b) (2)]

Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no human clinical studies were deemed needed to support this submission.

IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]

The Alma Hybrid Laser System is as safe and effective as the predicate devices. The proposed Alma Hybrid Laser System has the same intended use and indications, similar technological characteristics, and the same principles of operation as its predicate devices. Thus, the Alma Hybrid Laser System is substantially equivalent to its predicate

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.