The Candela Q-Switched Alexandrite Laser consists of an Alexandrite laser head, power supply and deionized water circulator The laser head contains 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 Candela Q-Switched Alexandrite Laser delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. When the Q-switching mechanism is disabled the system has the capability of producing a laser pulse duration of 0.050 - 0.120 milliseconds. 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 Q-Switched Alexandrite Laser supports 2mm, 3mm, and 5mm nominal spot sizes.

AI/ML Overview

The provided text is a 510(k) summary for the Candela Q-Switched Alexandrite Laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

It is crucial to understand that 510(k) summaries, especially for older or non-AI/software devices, often do not contain the type of detailed clinical study information requested. The purpose of a 510(k) is to show substantial equivalence, not necessarily to prove new high-level efficacy or to conduct comprehensive clinical trials with the rigor you're asking about (e.g., MRMC studies, specific acceptance criteria for performance metrics like sensitivity/specificity).

Based on the provided text, I can answer some of your questions, but many will be marked as "Not Applicable" or "Not Provided" because the document does not contain that information, consistent with the nature of a 510(k) for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) summary does not present specific quantitative performance metrics (like sensitivity, specificity, accuracy) or formal acceptance criteria for these metrics for the Candela Q-Switched Alexandrite Laser. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological features, and design aspects, rather than proving a new level of clinical performance against defined criteria.

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

Not Applicable / Not Provided. The document does not describe a clinical test set in the manner typically associated with AI/software performance evaluation. The substantial equivalence argument is based on the device's design, functional features, and intended use being similar to existing (predicate) devices. There is no mention of a "test set" of clinical cases for performance evaluation.

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

Not Applicable / Not Provided. As no test set for clinical performance evaluation is described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. No test set or performance study is described that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable / Not Provided. The document does not describe a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a laser system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not Applicable / Not Provided. This device is a physical laser system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

Not Applicable / Not Provided. No clinical performance ground truth is mentioned. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.

8. Sample Size for the Training Set

Not Applicable / Not Provided. Given this is a physical laser system, the concept of a "training set" (as in machine learning) does not apply. The device's design and manufacturing rely on engineering principles, established medical device standards, and the precedent set by predicate devices.

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

Not Applicable / Not Provided. As there is no "training set" in the context of this device, this question is not relevant.

Summary of Device and 510(k) Approach:

The K081324 submission for the Candela Q-Switched Alexandrite Laser is a classic example of a 510(k) for a physical medical device. The core argument for clearance is substantial equivalence to previously cleared predicate devices, specifically:

Candela Q-Switched Alexandrite Laser, K073534
Candela 3630 Laser System (Alexandrite) K063074
Cynosure Accolade Elite Laser (Alexandrite) K072868 (and K034030, possibly updated in the summary)

The rationale for equivalence is based on:

Same Intended Use: Treatment of pigmented lesions and tattoos.
Similar Functional Features: Power output, spot size, repetition rate, energy, fluence.
Matches Key Design Aspects: Wavelength (755 nm Alexandrite), light generation medium, power supply, cooling, and controls system.
Similar Methods of Assembly and Operation.

The document states, "Candela believes that there are no new questions of safety or effectiveness raised and the Candela Q-Switched Alexandrite Laser is substantially equivalent to the current legally marketed Candela Q-Switched Alexandrite Laser... in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices."

Therefore, the "acceptance criteria" for this submission were essentially the FDA determining that the new device did not raise new questions of safety or effectiveness compared to the predicates and that its technological characteristics were sufficiently similar to establish substantial equivalence. No explicit quantitative performance metrics or clinical study data of the type requested were provided or required for this 510(k).

Summary

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K081324

Image /page/0/Picture/1 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is made up of several horizontal lines, and the word "CANDELA" is written in a simple, sans-serif font.

510(k) Summary

JUN 1 7 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

Company Name:	Candela Corporation
Company Address:	530 Boston Post Road
	Wayland, MA 01778
Company Phone:	508-358-7400
Company Facsimile:	508-358-5602
Contact Person:	Lisa LaCroix
	Senior Regulatory Affairs Specialist
Date summary Prepared:	May 9, 2008
Device Identification
Device Trade/Proprietary Name:	The Candela Family of Q-Switched AlexandriteLasers
Common Name:	Q-Switched Alexandrite Laser

Classification Name: Laser Surgical Instrument, for use in General and Plastic Surgery and Dermatology Classification Requlation: 21 CFR § 878.4810 Device Classification: =

ldentification of Predicate Device

Predicate Device(s):	Candela Q-Switched Alexandrite Laser, K073534
	Candela 3630 Laser System (Alexandrite) K063074
	Cynosure Accolade Elite Laser (Alexandrite) K072868

Device Description

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handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.

Description of Intended Use

The Candela Family of Q-Switched Alexandrite Lasers are indicated for treatment in the following uses:

Pigmented Lesions Tattoos

Rationale for Substantial Equivalence

The Candela Q-Switched Alexandrite Laser 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 Q-Switched Alexandrite Laser 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 K073534, Candela 3630 Laser Systems, Alexandrite, K063074 and Cynosure Apogee Elite Laser, Alexandrite, K034030 predicate devices.

Safety and Effectiveness Information

Candela believes that there are no new questions of safety or effectiveness raised and the Candela Q-Switched Alexandrite Laser is substantially equivalent to the current legally marketed Candela Q-Switched Alexandrite Laser, K073534, Candela 3630 Laser System (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.

Conclusion

Based on the similarities in indications for use, design features, and functional features, the Candela Q-Switched Alexandrite Laser has been shown to be substantially equivalent to the current legally marketed predicate devices.

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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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Candela Corporation % Ms. Lisa LaCroix Senior Regulatory Affairs Specialist 530 Boston Post Road Wayland, Massachusetts 01778

Re: K081324

Trade/Device Name: Candela O-Switched Alexandrite Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 9, 2008 Received: June 10, 2008

JUN 1 7 2008

Dear Ms. LaCroix:

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

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Page 2 - Ms. Lisa LaCroix

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.

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. Millican

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 Statement

510(k) Number (if known): __

Device Name: Candela Q-Switched Alexandrite Laser

Indications for Use:

The Candela Q-Switched Alexandrite Laser is indicated for the following uses:

Pigmented Lesions Tattoos

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nelle Ogl for man
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K081324

Page 1 of 1

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.