The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: Y AG Handpiece Accessories are indicated for the following uses:

Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Device Description

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 Nd:YAG Handpiece Accessory consists of a cylindrical housing connecting to the distal end of the optical fiber which plugs into the standard Candela Family of Q-Switched Alexandrite Laser (AlexLaze) systems. The fiber carries the 755nm light from the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems to the handpiece at the distal end where the wavelength conversion from 755mm to 532nm occurs. The principle of operation is outlined here. The 755nm light is focused by focusing lenses to a 2mm beam waist within an Nd: YAG rod situated in the heart of the converter module. It is known that Nd: Y AG can be pumped at 755nm and made to lase at 1064nm with high efficiency. The Nd: YAG rod has two appropriately coated mirrors, one on either side, to form a laser resonator. Within the laser resonator is a Brewster Plate which ensures that the output 1064nm beam is polarized (in another variation of the same scheme, the Nd:YAG will be replaced by Nd:YVO4 or similar gain medium which provides a naturally polarized output, eliminating the need for a Brewster Plate). The output of the Nd: YAG laser has the same pulse duration as the original 755nm laser, but the wavelength is now 1064mm. The 1064nm beam is then incident on a KTP crystal that is aligned for optimum phase matching for second harmonic generation at 1064mm. The KTP crystal converts 1064mm to 532nm efficiently. A dichroic beam-splitter separates the 532nm beam from the residual unconverted 1064m. The 532nm beam is appropriately shaped and sized using lenses and is incident on the skin during treatment. The unconverted 1064nm that is rejected by the beam-splitter is safely absorbed in a beam dump within the module.

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 1064 Nd: YAG Handpiece Accessory is very similar to the 532nm handpiece except that there is no KTP crystal for the 1064nm to 532nm conversion. The beam is extracted immediately after the Nd: Y AG laser resonator.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical studies in the same way a PMA submission would. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of submission.

However, I can extract the information that is present in the document to address the spirit of your request regarding the device's characteristics and the basis for its market entry.

Here's an analysis based on the provided text:

Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: YAG Handpiece Accessories

Manufacturer: Candela Corporation

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

Since this is a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to predicate devices. The "reported device performance" is framed in terms of shared characteristics and intended use with these predicates. The document doesn't present a table of quantitative performance metrics against specific acceptance thresholds in the way a clinical trial might. Instead, it highlights the similarity in functional features and design aspects to establish equivalence.

Feature/Criterion (Implied by Substantial Equivalence Claim)	Reported Device Performance (as similar to predicates)
Intended Use	Shares the same intended uses as predicate devices.
Functional Features	Similar power output, spot size, repetition rate, energy, and fluence.
Key Design Aspects	Similar wavelength, light generation medium, power supply, cooling and controls system.
Method of Assembly	Similar to predicate devices.
Method of Operation	Similar to predicate devices.
Safety and Effectiveness	Risks and benefits are comparable to predicate devices; no new questions of safety or effectiveness raised.

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 (N/A) / Not provided.
- 510(k) submissions for devices like this typically rely on engineering testing, performance comparisons with predicate devices, and sometimes bench testing, rather than large-scale human clinical "test sets" in the manner of a drug or novel high-risk device. The document does not describe patient-based testing or clinical study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A / Not provided.
- As noted above, this submission focuses on substantial equivalence based on technical specifications and intended use, not clinical "ground truth" derived from expert consensus on patient data.

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

N/A / Not provided.
- No clinical "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

N/A / Not provided.
- This device is a laser system, not an AI-assisted diagnostic or therapeutic tool for human readers. MRMC studies are not relevant here.

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

N/A / Not provided.
- This is a hardware medical device (laser handpiece accessories), not a standalone algorithm.

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

N/A / Not provided (in the context of clinical ground truth).
- The "ground truth" in this submission relates to engineering specifications and performance characteristics, verified through internal testing and comparison to established predicate device specifications, rather than clinical outcomes or pathology data.

8. The sample size for the training set

N/A / Not provided.
- This type of device does not involve a "training set" in the machine learning sense.

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

N/A / Not provided.
- As above, no training set or associated ground truth establishment is applicable to this submission.

Summary of the 510(k) Submission's Approach:

The provided document describes a 510(k) Premarket Notification for the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: YAG Handpiece Accessories. The primary method for proving the device meets "acceptance criteria" (in this context, regulatory acceptance for market entry) is by demonstrating Substantial Equivalence to already legally marketed predicate devices.

The study presented here is an equivalence comparison, not a clinical trial establishing efficacy or safety against a specific endpoint with patient data. It argues that the new device shares:

Same intended use: Tattoo Removal, Treatment of Vascular Lesions, Treatment of Pigmented Lesions, Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology.
Similar functional features: Power output, spot size, repetition rate, energy, and fluence.
Similar key design aspects: Wavelength (after conversion), light generation medium, power supply, cooling, and controls system.
Similar methods of assembly and operation.

Therefore, the conclusion is that because of these similarities, the device's risks and benefits are comparable to the predicate devices, and no new questions of safety or effectiveness are raised. This allows the device to be marketed without requiring a more extensive PMA (Premarket Approval) process that would involve comprehensive clinical trials and detailed performance data against pre-defined acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" in all caps on the right. The flame is black and white, with horizontal lines inside the flame shape. The word "CANDELA" is in a simple, sans-serif font.

K063072

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
Company Address:	530 Boston Post RoadWayland, MA 01778	DEC 20 2006
Company Phone:	508-358-7400
Company Facsimile:	508-358-5602
Contact Person:	Mr. Jeffrey RobertsManager, Regulatory Affairs
Date summary Prepared:	10/05/06
Device Identification

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

	(AlexLAZR) Systems: 532 and 1064 Nd:YAG Handpiece
	Accessories
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):	Hoya ConBio, Inc., formerly Continuum Electro-Optics, Inc.
	Medlite C3 Q-Switched Nd:YAG Laser, K011677
	Candela Q-Switched, Frequency Doubled, Nd:YAG LaserSystem, K942152
	Candela Q-Switched Alexandrite Laser (AlexLAZR), K955662

Device Description

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ensures that the output 1064nm beam is polarized (in another variation of the same scheme, the Nd:YAG will be replaced by Nd:YVO4 or similar gain medium which provides a naturally polarized output, eliminating the need for a Brewster Plate). The output of the Nd: YAG laser has the same pulse duration as the original 755nm laser, but the wavelength is now 1064mm. The 1064nm beam is then incident on a KTP crystal that is aligned for optimum phase matching for second harmonic generation at 1064mm. The KTP crystal converts 1064mm to 532nm efficiently. A dichroic beam-splitter separates the 532nm beam from the residual unconverted 1064m. The 532nm beam is appropriately shaped and sized using lenses and is incident on the skin during treatment. The unconverted 1064nm that is rejected by the beam-splitter is safely absorbed in a beam dump within the module.

Description of Intended Use

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: YAG Handpiece Accessories are indicated for the following uses:

Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Rationale for Substantial Equivalence

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: YAG Handpiece Accessories have the same intended use and 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: 532 and 1064 Nd: YAG Handpiece Accessories shares similar methods of assembly, method of operation and intended uses, and therefore is substantially equivalent to the currently legally marketed Hoya ConBio Inc., Medlite C3 Q-Switched Nd:YAG Laser, K011677, Candela Q-Switched, Frequency Doubled, Nd: YAG Laser System, K942152, and Candela Q-Switched Alexandrite Laser (AlexLAZR), K955662.

Safety and Effectiveness Information

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: Y AG Handpiece Accessories are substantial equivalent to the currently legally marketed Hoya ConBio Inc., Medlite C3 Q-Switched Nd: YAG Laser, K011677, Candela O-Switched, Frequency Doubled, Nd: YAG Laser System. K942152, and Candela O-Switched Alexandrite Laser (AlexLAZR), K955662 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices.

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We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems: 532 and 1064 Nd: YAG Handpiece Accessories.

Conclusion

Base on the similarities in indications for use, design features, and functional features Candela Family of Q-Switched Alexandrite Laser (Alex147R) Systems: 532 and 1064 Nd: YAG Handpiece Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2006

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

Re: K063072

Trade/Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: Y AG Handpiece Accessories 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: October 5, 2006 Received: October 10, 2006

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

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Page 2 - Mr. Jeffrey Roberts

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and

Kumn
DEP
D

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K063072

Device Name: Candela Family of O-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd. YAG Handpiece Accessories

Indications for Use:

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: Y AG Handpiece Accessories are indicated for the following uses:

Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number K062072

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.