Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, 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. and the treatment of wrinkles.

New indication : Treatment of Inflammatory Acne Vulgaris

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

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

Device Description

The Cbeam is a 585 nm flash-lamp excited pulse dye medical laser, controlled by an embedded microprocessor., to be used for the treatment of benign cutaneous vascular lesions, such as facial and leg telangicctasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of CivatTe and benign cutaneous lesions, such as warts, scars, striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology. Treatment of wrinkles and the treatment of inflammatory acne vulgaris. The Cbeam laser may be 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 or 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 Cbeam Pulse 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

This 510(k) summary describes a device that is substantially equivalent to a predicate device, and thus does not include a study to prove meeting acceptance criteria in the sense of a novel device performance study. Instead, the "acceptance criteria" are the demonstration of substantial equivalence to a legally marketed predicate device, primarily through matching various design and operating characteristics.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstrated Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Intended Use	The device has the same intended use: photocoagulation of benign cutaneous vascular lesions (facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civatte), benign cutaneous lesions (warts, scars, striae, psoriasis), benign cutaneous and vascular lesions in gynecology, treatment of wrinkles, and treatment of inflammatory acne vulgaris (new indication).
Operating Principles	Utilizes similar operating principles (585 nm flash-lamp excited pulse dye medical laser, microprocessor controlled, optical fiber to handpiece, optional Dynamic Cooling Device).
Key Design Aspects	Matches key design aspects, including similar spot size (5, 7, 10 mm), the same wavelength (585 nm), and/or the same maximum delivered power.
Methods of Assembly	Similar methods of assembly to the predicate device.
Method of Operation	Similar methods of operation to the predicate device.
Safety Standards Conformance	Conforms to the Laser Performance Standard (21 CFR 1040), UL 2601 Electrical Safety Standard, and harmonized standard EN 60601-1-2.

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the 510(k) Premarket Notification itself, which aims to demonstrate substantial equivalence to identified predicate devices (Candela Cbeam Pulse Dye Laser (K020958) and ICN Photonics NLite (K024189)).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device's submission is for substantial equivalence, not a clinical trial. Therefore, there is no "test set" in the context of clinical data or patient samples used for demonstrating performance in this 510(k) summary. The testing mentioned refers to engineering and safety standards conformance, not clinical performance data from a patient cohort.

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 there is no clinical "test set" in the context of patient data, no experts were used to establish ground truth for such a set within this submission.

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

Not applicable. There was no clinical "test set" requiring adjudication.

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

Not applicable. This device is a laser system, not an AI or diagnostic imaging device that would typically involve a multi-reader multi-case comparative effectiveness study with human readers.

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

Not applicable. This device is a physical laser system, not an algorithm.

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

Not applicable in the context of a clinical performance study. The "ground truth" for this submission is the established performance and safety of the predicate devices. The new indication for Inflammatory Acne Vulgaris would typically require clinical data, but this summary doesn't detail it. The FDA's letter states the device is substantially equivalent "for the indications for use stated in the enclosure," which includes the new indication, implying that sufficient data (if required for new indication) was provided elsewhere or relied on existing literature/predicate's data.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for a laser device in this type of submission.

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

Not applicable.

Summary

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JAN 1 6 2004

Cbeam 510k Summary

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510(k) Summary

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela Cbeam Pulse Dye Laser System, which is substantially equivalent to previously marketed device intended for photocoagulation of benign cutaneous vascular lesions, 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, striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in Gynecology, treatment of wrinkles and the treatment of inflammatory acne vulgaris. There have been no modifications to design to the Cbeam Pulse Dye Laser as cleared under K020958.

Submitted by:	Candela Corporation530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Lorraine Calzetta
Date prepared:	October 10, 2003
Classification:	Class II (21 CFR § 878.4810 Laser Surgical Instrument for usein General and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, Cbeam Pulse Dye Laser System
Predicate Devices:	Candela Cbeam Pulse Dye Laser (K020958), ICN PhotonicsNLite (K024189)

Description:

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Testing:

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

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela Corporation believes that its Candela Cbeam Laser System is substantially equivalent to the predicate device.

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JAN 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033331

Trade/Device Namc: Candela Cbeam Pulse Dye 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: October 15, 2003 Received: October 24, 2003

Dear Ms. Calzetta Patrovic:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalcnt (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 Mcdical Device Amendments, or 10 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 adultcration.

If your device is classified (see above) into cither 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 Patrovic

'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): ヒ○ろろろろ /

Device Name: Candela Cbeam Pulse Dye Laser System

Indications For Use:

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

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

For treatment of benign cutaneous vascular lesion, 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. and the treatment of wrinkles.

New indication : Treatment of Inflammatory Acne Vulgaris

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)

Miriam C. Provost
Division Sign Off

Division of General, Restorative and Neurological Devices

Number K03331

Prescription Use X (Pcr 21 CFR 801.109) Over-The-Counter Use

(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.