The Diode laser is a continuous wave, diode medical laser, controlled by an embedded processor, to be used for use in dermatology for treatment of periorbital wrinkles. The laser system operates with a Dynamic Cooling Device, which provides a short burst of cryogen spray during the laser treatment. The laser output energy is delivered via an optical fiber to a hand piece, which produces a circular beam on the skin. The cryogen is delivered via a hose to a nozzle located in the hand piece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment.

The Candela Smoothbeam system is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device.

The Candela Smoothbeam Laser is equipped with safety interlock systems to protect patients and operators. Users of the device make selections from a control panel to regulate operation during treatment.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Candela Smoothbeam System, presented in the requested format:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety & Effectiveness for treatment of facial wrinkles	Substantially equivalent to predicate devices (Cool Touch Laser for fine lines/wrinkles, Candela Smoothbeam for periorbital wrinkles and atrophic acne scars) based on identical or similar operating principles, design aspects (spot size, wavelength, max power).
Conformance to Laser Performance Standard (21 CFR 1040)	The device conforms.
Conformance to UL 544 electrical safety standard	The device conforms.
Conformance to Essential Requirements of European Union Medical Device Directives	The device conforms.

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

The provided text does not contain information about a specific clinical study with a test set for the new indication of "treatment of facial wrinkles." The submission relies on demonstrating substantial equivalence to predicate devices, rather than presenting new clinical study data for this specific claim. Therefore, information about sample size and data provenance for a test set is not available in this document.

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

Since no new clinical study data is presented for the "treatment of facial wrinkles" indication, no information is available regarding experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

As no new clinical study data is presented for the "treatment of facial wrinkles" indication, no information is available regarding adjudication methods.

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

No MRMC comparative effectiveness study was done as part of this 510(k) submission. The submission focuses on substantial equivalence to predicate devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This device is a physical laser system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable.

7. Type of Ground Truth Used

For the new indication of "treatment of facial wrinkles," the "ground truth" implicitly used for the substantial equivalence claim is the demonstrated effectiveness and safety of the predicate devices (Cool Touch Laser for fine lines and wrinkles, and Candela Smoothbeam for periorbital wrinkles and atrophic acne scars). The assumption is that because the new device operates on identical/similar principles and design, it will achieve similar outcomes. No new, independent ground truth (e.g., pathology, outcomes data from a new trial) was established for this specific 510(k).

8. Sample Size for the Training Set

There is no information about a "training set" as this 510(k) submission is for a physical medical device (laser system), not an AI/machine learning algorithm that requires training data.

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

As there is no training set for an AI/machine learning algorithm, this question is not applicable.

Summary

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K 030846

510(k) Summary

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela Smoothbeam System, which is substantially equivalent to a previously marketed device intended for use in treatment of facial wrinkles.

Submitted by:	Candela Corporation530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Lorraine Calzetta
Date prepared:	June 09, 2003
Trade Name:	Candela Smoothbeam Laser System
Common Name:	Dermatology Laser System
Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for use inGeneral and Plastic Surgery and in Dermatology)
Predicate Device:	Laser Aesthetics CoolTouch (K022817) and Candela Mid IR DiodeLaser System aka Smoothbeam Laser (K022884)

Description:

The Candela Smoothbeam system is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device.

Testing:

As a laser product, the Smoothbeam Laser is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition, the device conforms to the UL 544 electrical safety standard and the Essential Requirements of the European Union Medical Device Directives.

Safety and Effectiveness information

The Smoothbeam Laser described in this submission is identical to the Smoothbeam laser cleared for the Indications of treatment of periorbital winkles (K013825) and Atrophic acne scars (K022884) Candela believes that no new issues of safety or effectiveness are raised by the introduction to market the Smoothbeam Laser for the treatment of facial winkles.

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Summary of Substantial Equivalence:

The indication for use for the treatment of facial wrinkles is based on substantial equivalence to the Cool Touch Laser, which is cleared for use for the treatment of fine lines and wrinkles (K022817). Additionally, the Candela Smoothbeam Laser utilizes the identical or similar operating principles, matches key design aspects, including same spot size, same of similar wavelength and same maximum delivered power as the predicate devices. On this basis, Candela believes that the Candela Smoothbeam Laser System is substantially equivalent to the predicate devices for the same indications for use.

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 6 2003

Ms. Lorraine Calzetta Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778

Re: K030846

Trade/Device Name: Candela Smoothbeam 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: II Product Code: GEX Dated: June 9, 2003 Received: June 20, 2003

Dear: Ms. Calzetta:

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 - Ms. Lorraine Calzetta

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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): K030846

Candela Corporation Smoothbeam Laser System Device Name:

Indications For Use:

The Candela Smoothbeam Laser System is indicated for use in the treatment of facial wrinkles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

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Over-The-Counter Use

Miriam C. Provost

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

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.