Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte, and benign cutaneous lesions, such as warts, scars, stries and psoriasis. Periorbital wrinkles and the treatment of wrinkles.

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

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

Device Description

The Vbeam is a 595 nm flash-lamp excited pulsed dye medical laser, controlled by an embedded microprocessor, to be used for the treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatee and benign cutaneous lesions, such as warts, scars, stries and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of periorbital wrinkles. The Vbeam laser is used with the Candela Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 5, 7, 10 and 3 x 10 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.

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

AI/ML Overview

The provided 510(k) summary for the Candela Vbeam Pulsed Dye Laser System does not contain detailed acceptance criteria for wrinkle reduction or specific study data to prove the device meets such criteria.

The submission primarily focuses on establishing substantial equivalence to predicate devices for a broad range of dermatological and vascular lesions, as well as wrinkles, based on similar intended use and technical specifications (wavelength, power, spot size). While "Treatment of periorbital wrinkles and wrinkles" is listed as an indication for use, the document does not present any clinical study data or performance metrics related to wrinkle reduction that would define acceptance criteria or demonstrate the device's efficacy for this specific indication.

Therefore, many of the requested details about acceptance criteria and a study to prove they are met cannot be extracted from this document for the wrinkle indication.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria: Not explicitly stated for wrinkle reduction. The 510(k) relies on substantial equivalence to predicate devices, implying that if the device is similar to previously cleared devices for wrinkle treatment, it is considered safe and effective without new efficacy criteria being defined or met through a specific study.
Reported Device Performance: Not reported for wrinkle reduction. The document does not provide efficacy rates, clinical improvement percentages, or any quantitative measures for wrinkle treatment.

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 as no specific clinical study data for wrinkle reduction is presented in this document.

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 as no specific clinical study data for wrinkle reduction is presented in this document.

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

Not applicable as no specific clinical study data for wrinkle reduction is presented in this document.

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

This device is a medical laser system, not an AI-based diagnostic or therapeutic tool that relies on "readers" or "AI assistance." Therefore, an MRMC study is not relevant to its clearance.

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

This is a standalone medical device (a laser system) and does not involve an algorithm separate from human operation. Its performance is directly tied to the physical output of the laser and the skill of the human operator.

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

Not applicable as no specific clinical study data for wrinkle reduction is presented in this document. The clearance is based on substantial equivalence.

8. The sample size for the training set

Not applicable. This device is a laser system, not an AI model that requires a training set of data.

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

Not applicable. This device is a laser system, not an AI model.

Summary of Device Clearance Information Provided:

The Candela Vbeam Pulsed Dye Laser System received 510(k) clearance (K021180) based on its substantial equivalence to previously marketed devices (Candela Vbeam Pulsed Dye Laser (K013784) and SLS Biophile Ltd NLite (K013461)).

The rationale for equivalence includes:

Intended Use: Similar (e.g., photocoagulation of benign cutaneous vascular lesions, benign cutaneous lesions, treatment of periorbital wrinkles and wrinkles).
Operating Principles: Utilizes similar principles (595 nm flash-lamp excited pulsed dye laser).
Design Aspects: Matches key design aspects, including similar spot size, the same wavelength, and/or the same maximum delivered power as the predicate devices.

The clearance is primarily based on the device conforming to safety standards (Laser Performance Standard 21 CFR 1040, UL 2601 Electrical Safety Standard, EN 60601-1-2) rather than presenting new clinical efficacy data for the wrinkle indication in this specific 510(k) summary.

Summary

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Candela Corporation Vbeam PDL Wrinkle Indication 510k Summary

JUL - 2 2002

Image /page/0/Picture/2 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 black and has horizontal lines running through it. The word "CANDELA" is in a simple, sans-serif font.

K021180

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela Vbeam Pulsed Dye Laser System, which is substantially equivalent to previously marketed devices intended for photocoagulation of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatee and benign cutaneous lesions, such as warts, scars, striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of periorbital wrinkles and wrinkles.

Submitted by:	Candela Corporation530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Lorraine Nelson
Date Prepared:	April 11, 2002
Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for usein General and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, Vbeam Pulsed Dye Laser System
Predicate Devices:	Candela Vbeam Pulsed Dye Laser (K013784), SLS Biophile LtdNLite (K013461)

Description:

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Testing:

As a laser product, the Vbeam Pulsed Dye Laser is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the Vbeam conforms 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.

Summary of Substantial Equivalence:

The Candela Vbeam Laser has the same intended use, utilizes similar operating principles and matches key design aspects, including similar spot size, the same wavelength and / or the same maximum delivered power as the predicate devices.

On the basis of similarities in methods of assembly, method of operation, clinical performance data and intended uses, Candela Corporation believes that its Candela Vbeam Laser System is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Candela Corporation Lorráine Nelson Manager, Regulatory Affairs 530 Boston Post Road Wayland. Massachusetts 01778-1886

Re: K021180

Trade Name: Candela Vbeam Pulsed Dye Laser System Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: April 11, 2002 Received: April 15, 2002

Dear Ms. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 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 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 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,

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): __ K O2118 D

Device Name: Candela Vbeam Pulsed Dye Laser System

Indications For Use:

The Candela Vbcam Pulsed Dye Laser is indicated for the following uses in:

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

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number	K021180
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Prescription Use (Per 21 CFR 801.109)	X OR Over-The-Counter Use
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(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.