Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, angioma, spider angioma, poikiloderma of Civatte and benign cutaneous lesions, such as warts, scars, striae, and psoriasis. Treatment of periocular wrinkles.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

Device Description

The Vbeam Pulse Dye laser is a 595 nm, flash lamp excited pulsed dye medical laser, controlled by an embedded microprocessor. The Vbeam Pulse Dye Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular or elliptical laser beams onto the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. 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 Vbeam Pulse Dye Laser is equipped with a safety interlock system to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

AI/ML Overview

This document describes the Candela Vbeam Pulse Dye Laser System, a medical device for the photocoagulation of benign cutaneous lesions and vascular lesions. The information provided is primarily focused on demonstrating substantial equivalence to predicate devices for regulatory purposes.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance

The provided document does not list specific acceptance criteria as quantitative thresholds that the device must meet (e.g., "device must achieve X accuracy"). Instead, the "acceptance criteria" are implicitly understood as demonstrating substantial equivalence to predicate devices. The "device performance" is described in terms of its characteristics and intended use being similar to these predicates.

Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use Equivalence: Same indications for use as predicate devices.	The Candela Vbeam Pulse Dye Laser System is indicated for photocoagulation of benign cutaneous lesions (warts, scars, striae, psoriasis) and benign vascular lesions (facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, poikiloderma of Civatte, periocular wrinkles) in General Surgery, Dermatology/Plastic Surgery, Gynecology, and Podiatry. This is explicitly stated as being the same as predicate devices.
Operating Principles Equivalence: Utilizes similar operating principles.	The device is a 595 nm, flash lamp excited pulsed dye medical laser, controlled by an embedded microprocessor. It delivers laser output via an optical fiber to a handpiece, with a Dynamic Cooling Device for skin cooling. The document claims it "utilizes similar operating principles" as predicate devices.
Key Design Aspects Equivalence: Matches key design aspects (spot sizes, pulse durations, wavelength, maximum delivered energy).	The device's wavelength is 595 nm. It includes a Dynamic Cooling Device. The document explicitly states it "matches key design aspects, including spot sizes, pulse durations, wavelength and the same maximum delivered energy as the predicate devices."
Safety and Standards Conformance: Conforms to relevant safety and performance standards.	As a laser product, it conforms and will conform to Laser Performance Standards (21 CFR 1000 - 1040). It will also conform to UL 2601 Electrical Safety Standard and Harmonized Standard EN 60601-1-2.

Study Details

The provided document does not describe a clinical study or performance study in the way you've outlined. Instead, it's a 510(k) premarket notification for demonstrating substantial equivalence based on technical and intended use comparisons to existing predicate devices. Consequently, many of your requested details are not applicable or available in this type of submission.

Here’s a breakdown based on the provided text:

Sample size used for the test set and the data provenance:
- N/A. No clinical "test set" and associated data provenance (e.g., country of origin, retrospective/prospective) are mentioned. The submission relies on comparative analysis with predicate devices and compliance with engineering standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No clinical "test set" requiring expert-established ground truth is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical "test set" requiring an adjudication method is described.
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:
- No. This device is a laser system, not an AI-assisted diagnostic or therapeutic tool that would involve "human readers" or "AI assistance." Therefore, an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware laser system with software controls, not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A. Since no clinical performance study for the Vbeam Pulse Dye Laser System itself is detailed, there's no mention of ground truth establishment for a test set. The "ground truth" in this context is the established safety and efficacy of the predicate devices to which the Vbeam is compared.
The sample size for the training set:
- N/A. No "training set" for an algorithm or AI model is applicable to this device type or submission.
How the ground truth for the training set was established:
- N/A. See point 7.

In summary, the provided document is a 510(k) summary focused on demonstrating the substantial equivalence of the Candela Vbeam Pulse Dye Laser System to previously cleared predicate devices based on its intended use, operating principles, and design aspects. It does not contain information about a clinical performance study with defined acceptance criteria, test sets, ground truth establishment, or clinical efficacy data as one might find for a novel diagnostic or AI-powered device. The "testing" mentioned refers to compliance with laser performance and electrical safety standards.

Summary

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Image /page/0/Picture/1 description: The image shows the Candela logo and the date FEB 11 2002. The Candela logo is a stylized image of a flame. The text "CANDELA" is written in all caps below the logo. The date is written in a simple, sans-serif font.

510(k) Summary

General Information:

Ocuchar Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Vbeam Pulse Dye I ms > Pro vio to provide is substantially equivalent to previously marketed devices intended for the photocoagulation of benign cutaneous lesions, such as warts, scars, striea and psoriasis; benign photocoughanon of oting, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, poikiloderma of Civatte and in gynecology and treatment of periocular wrinkles.

Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for usein General and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, Vbeam Pulse Dye Laser System
Predicate Devices:	Candela Clearbeam Pulse Dye Laser System (K013043)
	Candela SPTL-1e Pulse Dye Laser (K011092)
	Candela Long Pulsed Dye Laser (K993671)
	Candela SPTL Long Pulse/Tunable Pulse Dye Laser (K943292,K954934)
	SLS Biophile Ltd. NLite Pulse Dye Laser (K000811)

Description:

Testing:

As a laser product, the Vbeam Pulse Dye Laser is required to conform and will conform to the Laser Performance Standards (21 CFR 1000 - 1040). In addition, the device will conform to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by and required by the European Community (EC).

Summary of Substantial Equivalence:

The Candela Vbeam Pulse Dye Laser System has the same intended use, utilizes similar operating principles and matches key design aspects, including spot sizes, pulse durations, wavelength and the same maximum delivered energy as the predicate devices.

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Candela Vbeam Pulse Dye Laser is substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2002

Mr. L. Nelson Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778

Re: K013748

Ro15746
Trade/Device Name: Candela Vbeam Pulse Dye Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 12, 2001 Received: November 13, 2001

Dear Mr. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobare) to tegains and ment date of the Medical Device American be of the depend commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de necs that have been require approval of a premarket approval application (PMA). alla Cosmette 71ct (71ct) that as not of corporal controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provisioning 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 If your device is elassined (600 a00 otrols. 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 r loase of acrised a determination that your device complies with other requirements of the Act that I Dr Has Internand regulations administered by other Federal agencies. You must or any I odolar statutes and regionements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF It Furt 6077, adoling (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. L. Nelson

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 promated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

for 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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510(k) Number (if known): _ | _ 013748

Device Name: Candela Vbeam Pulse Dye Laser System

Indications For Use:

The Candela Vbeam Pulse Dye Laser System is indicated for the following uses in:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

For treatment of benign cutaneous vascular lesions, such as facial Dermatology/Plastic Surgery: and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, poikiloderma of Civatte and benign cutaneous lesions, such as warts, scars, striae, and psoriasis. Treatment of periocular wrinkles.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Musiam C. Provost

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

Prescription Use
(Per 21 CFR 801.109)

510(k) Number K013748

(Optional format 1-2-96)

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.