The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consist of an Alexandrite laser head, power supply and deionized water circulator. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems also contains a Q-switching mechanism which when disabled allows the laser system the capability of producing a laser pulse duration of 0.050 - 0.120 millisecond. The laser head contains the cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the control panel, which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature. The laser system is fully air cooled.

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.

A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems support 2mm, 3mm, and 4mm nominal spot sizes.

AI/ML Overview

This document is a 510(k) summary for the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documentation.

Instead, the document focuses on regulatory approval based on substantial equivalence to already legally marketed devices. This means the manufacturer is asserting that their new device is as safe and effective as existing ones, rather than necessarily performing a new study against specific acceptance criteria.

Therefore, most of the information requested in your prompt is not available in this document.

However, I can extract the following:

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

Not available. The document does not specify acceptance criteria or report performance data against such criteria. The basis for approval is substantial equivalence to predicate devices, not performance against new, explicit criteria.

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

Not applicable/Not available. No new test set data is presented for performance evaluation against acceptance criteria. The approval is based on substantial equivalence to predicate devices already on the market.

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/Not available. No new test set requiring expert ground truth is described.

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

Not applicable/Not available. No new test set requiring adjudication is described.

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/Not available. This device is a laser system, not an AI or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable/Not available. This device is a laser system, not an algorithm, so a standalone performance study in this context is not relevant.

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

Not applicable/Not available. No new ground truth is established for this submission. The rationale for approval is based on substantial equivalence to existing, legally marketed devices for which safety and effectiveness have already been established.

8. The sample size for the training set

Not applicable/Not available. This document describes a physical medical device (laser system), not a software or AI algorithm that would typically have a "training set."

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

Not applicable/Not available. As above, no training set is relevant to this device submission.

Summary based on the provided document:

The provided document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence of the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems to existing, legally marketed predicate devices. It explicitly states: "The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems has the same intended use, utilizes similar functional features... and matches key design aspects... as the predicate devices."

The determination of substantial equivalence means that "the risks and benefits are comparable to the predicate devices," and therefore, "there are no new questions of safety or effectiveness raised." As such, this document does not contain information on new acceptance criteria, device performance against such criteria, or new studies with test sets, expert ground truth, or training sets. The regulatory pathway chosen (510(k) for substantial equivalence) means such studies are generally not required if the new device is demonstrably similar to existing ones.

Summary

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Ko73534

Page 1 of 2

510(k) Summary

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

Company Name:	Candela Corporation	APR - 3 2008
Company Address:	530 Boston Post Road
	Wayland, MA 01778
Company Phone:	508-358-7400
Company Facsimile:	508-358-5602
Contact Person:	Mr. Jeffrey Roberts
	Manager, Regulatory Affairs
Date summary Prepared:	12/12/07

Device Identification

Device Trade/Proprietary Name: The Candela Family of Q-Switched Alexandrite Laser

	(AlexLAZR) systems
Common Name:	Q-Switched Alexandrite Laser
Classification Name:	Laser Surgical Instrument, for use in General and PlasticSurgery and Dermatology
Classification Regulation:	21 CFR § 878.4810
Device Classification:	II

Identification of Predicate Device

Predicate Device(s):	Candela Q-Switched Alexandrite Laser, (AlexLAZR), K063073Candela 3630 Laser Systems, Alexandrite, K063074Cynosure Apogee Elite Laser, Alexandrite, K034030
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Device Description

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0735 24

Page 292

Description of Intended Use

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for treatment in the following uses:

Pigmented Lesions Tattoos

Rationale for Substantial Equivalence

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems, has the same intended use, utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system), as the predicate devices.

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems shares similar methods of assembly, method of operation, and intended uses, and therefore is substantially equivalent to the current legally marketed Candela Q-Switched Alexandrite Laser, (AlexiAzR), K063073, Candela 3630 Laser Systems, Alexandrite, K063074 and Cynosure Apogee Elite Laser, Alexandrite, K034030 predicate devices.

Safety and Effectiveness Information

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is substantially equivalent to the current legally marketed Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems, K063073, Candela 3630 Laser Systems, Alexandrite, K063074, and Cynosure Apogee Elite Laser, Alexandrite, K034030 predicate devices in 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 the Candela Family of Q-Switched Alexandrite Laser (Alex1,AZR) systems

Conclusion

Base on the similarities in indications for use, design features, and functional features the Candela Family of Q-Switched Alexandrite Laser (Alex147R) systems has been shown to be substantially equivalent to the current legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms. The symbol is composed of three curved lines that converge at the center.

Public Health Service

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland. Massachusetts 01778

APR - 3 2008

Re: K073534

Trade/Device Name: Candela Family of O-Switched Alexandrite (Alexy A7R) systems 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: December 14, 2007 Received: December 17. 2007

Dear Mr. Roberts:

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 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); 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 - Mr. Jeffrey Roberts

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 N. Milliman

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):

Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems

Indications for Use:

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for the following uses:

Pigmented Lesions Tattoos

Prescription Use × (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)

Neil Rf Ogle Gormxn

(Division Sign-Off Division of General, Restorative, and Neurological Devices

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510(k) Number K073534

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.