The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.

The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for:

Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm
Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale -Recommended wavelength in the range of 535-950 nm
Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm

Device Description

The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlamp.

The total emission spectrum of a Xenon flashlamp is from around 300 nm in the UV to 1000 nm in the near IR. The light emitted from the lamp is collected by a reflector and focused into a rectangular, waveguide. Prior to entering the waveguide, the light is transmitted through a longpass optical filter which blocks all wavelengths below the "cut-off" wavelength of the filter. Thus when a 635nm filter is used, only light of wavelengths above 635 nm is emitted. Since the lamp is surrounded by a water cooling jacket, actual wavelength emission is up to about 950 nm, due to water absorption of longer wavelengths.

The BEAMAX/FORMAX family system is equipped with four different handpieces which can be attached for different clinical applications. These handpieces differ in the optical filter applied, hence in the optical spectrum emitted, as well as in the time duration of the pulses emitted. A microprocessor based system controller is used to monitor and direct all system functions and Man Machine Interface.

AI/ML Overview

The provided document is a 510(k) summary for the BEAMAX/ FORMAX Pulsed Light Device Family. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a new clinical study to establish acceptance criteria and device performance from scratch. Therefore, many of the typical elements of a study that prove a device meets acceptance criteria are not present.

However, based on the information provided, here's an attempt to answer the request by interpreting "acceptance criteria" as the criteria for substantial equivalence, and "study" as the comparison to predicate devices:

Acceptance Criteria and Device Performance Study for BEAMAX/FORMAX Pulsed Light Device Family

Overview

The BEAMAX/FORMAX Pulsed Light Device Family sought 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices, as opposed to conducting a de novo clinical trial with new performance acceptance criteria. The "acceptance criteria" here therefore refer to the criteria for substantial equivalence, and the "reported device performance" is framed by its similarity to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission, the "acceptance criteria" are the conditions under which the device is considered substantially equivalent to already cleared devices. The "reported device performance" is essentially that it matches or is comparable to these predicate devices for the specified indications.

Criteria Category	Acceptance Criteria (for Substantial Equivalence to Predicate Devices)	Reported Device Performance (as demonstrated by comparison)
Intended Use	Identical to legally marketed predicate devices.	The intended use and indications of the submitted BEAMAX/FORMAX family are identical to legally marketed devices: BEAMAX (K063249), Harmony XL™ (K072564), and Cutera (K050047).
Indications for Use	Identical or comparable to legally marketed predicate devices, without raising new questions of safety/effectiveness.	The proposed device family includes broader indications than a prior BEAMAX (K063249) but is similar to the broader IPL indications of Harmony XL™ (K072564) and Cutera (K050047). No new questions of safety or effectiveness are raised.
Technological Features	Similar technology, performance, and specifications to legally marketed predicate devices.	The device is a pulsed light energy device based on a filtered Xenon flashlamp, similar to the predicate devices. It operates with a total emission spectrum of 300 nm to 1000 nm, and uses longpass optical filters to block specific wavelengths. Specific handpieces cater to different applications, similar to predicate devices.
Risks and Benefits	Comparable to predicate devices.	Due to similarity in intended use, indications, and technological features, the risks and benefits are comparable to the predicate devices.
Safety & Effectiveness	No new questions of safety or effectiveness are raised.	The submission states that "there are no new questions of safety or effectiveness raised by the introduction of SharpLight's BEAMAX/FORMAX Fluorescent Pulsed Light Systems."

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

Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission, as direct human clinical outcome data from a "test set" for the new device is not provided. The "test" here is the comparison against the characteristics and established safety/effectiveness of predicate devices already on the market.
Data Provenance: The "data" for comparison comes from the regulatory filings and established performance of the identified predicate devices, which are already marketed in the US. There is no mention of country of origin for new clinical data, nor is there a distinction between retrospective or prospective data for a newly conducted study for this submission.

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

Number of Experts: Not applicable. Ground truth, in the context of a 510(k) for substantial equivalence, is established by the FDA's prior clearance of the predicate devices based on their safety and effectiveness. No new expert consensus panel was convened for this specific submission to establish a "ground truth" for a new test set.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Since there's no new test set with human subject data requiring expert review and adjudication for this submission, no adjudication method like 2+1 or 3+1 was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The documentation focuses on technological and indications-for-use equivalence rather than human reader performance with or without AI assistance. The device is a pulsed light system, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This device is an energy-based medical device (pulsed light system), not an algorithm or AI system. Its performance is inherent in its physical operation and energy delivery for therapeutic purposes.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's characteristics, intended use, and indications are compared against these established "truths" to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for such a set.

Summary

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K0r2876

510(k) Summary

NOV 1 0 2008

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.92

Submitter Information

SharpLight Technologies Ltd. 11 Moshe Levy St. Rishon Le Zion 75658, Israel Tel: (972) 3 9611969, Fax: (972) 3 9528890 Submission contact person: Ilan Sharon 29b Ben Gurion St. Zichron Yaacov 30900, Israel TEL: 972-4-8246632

RRR

11/2/24

Device Classification

Proprietary Device Name:	BEAMAX/ FORMAX Pulsed Light Device Family
Common name:	Fluorescent Pulsed Light System
Produt Code:	GEX
Classification Name:	Laser Surgical Instrument, for use in General and Plastic Surgeryand Dermatology
Classification Regulation:	21 CFR § 878.4810
Regulatory Class:	II

Identification of Legally Marketed Predicate Devices

Cutera Optional Pulsed Light Hand Piece Family - K050047 Alma - Harmony XL "" Multi-Application Platform - K072564 SharpLight – BEAMAX Pulse Light System -K063249

Device Description

The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlamp.

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Intended Use of Device

The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 -950 nm wavelengths (with and without contact-cooling) are indicated for:

Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction.

- Treatment of Vascular Lesions

Treatment of Inflammatory Acnc (acne vulgaris)

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Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.

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Safety & Effectiveness

The intended use and indications of the submitted BEAMAX/ FORMAX pulsed light system family is identical to the legally marked devices: BEAMAX (K063249 - for hear removal treatments); Harmony XLTm Multi-Application Platform (K072564); Cutera Optional Pulsed Light Hand Piece Family (K050047).

Similarity of intended use and intended use and technological features and therefore the risks and benefits are comparable to the predicate devices.

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of sharpLight's BEAMAX/ FORMAX Fluorescent Pulsed Light Systems.

Rational for Substantial Equivalency

Similarities:

The intended use and indications of the proposed modified BEAMAX/ FORMAX device family are similar to the legally marketed predicate devices.

The technology, performance and most of the specifications of the proposed modified BEAMAX/ FORMAX device family are similar to the legally marketed predicate devices Differences:

The proposed modified device family includes wider indications in reference to legally marked BEAMAX (K063249) indication for use that is limited to Hair removal only.

The proposed device family intended use and indications for use are similar to the IPL intended and indications for use of Harmony XLTm Multi-Application Platform (K72564) and Cutera Optional Pulsed Light Hand Piece Family (K050047) predicate devices (Other indications are related to optional Laser handpieces).

Substantial Equivalence Statement

Based on the above, it is Sharpl.ight's opinion that the proposed BEAMAX and FORMAX Pulsed Light Device Family is substantially equivalent in terms of design, functional features and safety & effectiveness to the unmodified BEAMAX (K63249) legally marketed device and to the legally marked predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2008

SharpLight Technologies, Ltd. % Ilan Sharon 11 Moshe Levy St Rishon Le Zion 75658, Israel

Re: K082876

Trade/Device Name: BEAMAX/FORMAX Pulsed Light Device Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: October 15, 2008 Received: October 21, 2008

Dear Ilan Sharon:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 mav 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); 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.

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Page 2 - Ilan Sharon

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark H. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K082876

Device Name: BEAMAX/ FORMAX Pulsed Light Device Family

Indications for Use:

The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for:

- Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm
- Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale -Recommended wavelength in the range of 535-950 nm
- Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
- Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

[K082876](https://510k.innolitics.com/search/K082876) Page 1_ of 1_

510(k) Number.

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.