← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K033331 # CANDELA CBEAM PULSE DYE LASER SYSTEM (K033331) _Candela Corp. · GEX · Jan 16, 2004 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K033331 ## Device Facts - **Applicant:** Candela Corp. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Jan 16, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended 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. 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, 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 Story Cbeam is a 585 nm flash-lamp excited pulse dye laser. Device uses embedded microprocessor to control laser output. Energy delivered via optical fiber to handpiece, producing circular beams (5, 7, or 10 mm). Optional Dynamic Cooling Device provides cryogen spray burst prior to laser pulse. Used in clinical settings by physicians for photocoagulation of vascular/cutaneous lesions, wrinkle treatment, and inflammatory acne vulgaris. Operators select parameters via onboard control panel. Safety interlocks protect patients and operators. Output energy causes photocoagulation of target tissue, facilitating lesion removal or skin condition improvement. ## Clinical Evidence Bench testing only. Device conforms to Laser Performance Standard (21 CFR 1040), UL 2601 Electrical Safety Standard, and EN 60601-1-2. ## Technological Characteristics 585 nm flash-lamp excited pulse dye laser. Embedded microprocessor control. Optical fiber delivery to handpiece. Circular beam diameters: 5, 7, 10 mm. Integrated Dynamic Cooling Device (cryogen spray). Safety interlocks. Conforms to 21 CFR 1040, UL 2601, and EN 60601-1-2. ## Regulatory 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. ## Predicate Devices - Candela Cbeam Pulse Dye Laser ([K020958](/device/K020958.md)) - ICN Photonics NLite ([K024189](/device/K024189.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ JAN 1 6 2004 Cbeam 510k Summary 033331 1/2 Image /page/0/Picture/3 description: The image shows the word "CANDELA" in a stylized font next to a logo. The logo is a stylized image of a flame. The flame is black on the left side and has horizontal lines on the right side. ### 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 Corporation
530 Boston Post Road
Wayland, MA 01778-1886 | |--------------------|---------------------------------------------------------------------------------------------------------------------| | Contact Person: | Lorraine Calzetta | | Date prepared: | October 10, 2003 | | Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use
in 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 Photonics
NLite (K024189) | ### 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. {1}------------------------------------------------ 03331 2/2 Image /page/1/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 on the left side and has horizontal lines on the right side. ### 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. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. 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. {3}------------------------------------------------ ## 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 {4}------------------------------------------------ Image /page/4/Picture/0 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 divided into two sections, with the left section being solid black and the right section consisting of horizontal lines. ### 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 OR Prescription Use X (Pcr 21 CFR 801.109) Over-The-Counter Use (Optional format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K033331](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K033331) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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