(90 days)
The Candela Family of Pulse Dye Laser Systems is indicated for the following uses: General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment 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, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.
The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses: General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment 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, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 3, 7 or 10, 12 or 3x10 millimeters on the skin. The Candela Family of Pulsed Dye Laser Systems 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.
The provided text is a 510(k) summary for the Candela Family of Pulsed Dye Lasers, dated June 13, 2005. It describes the device, its intended uses, and establishes substantial equivalence to predicate devices. However, it does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, or any of the detailed metrics typically associated with proving device performance.
This document is a regulatory submission demonstrating substantial equivalence for a medical device (a laser system), not a clinical study report. Therefore, it does not include the type of information requested about acceptance criteria and device performance evaluation. The "Testing" section only mentions conformity to laser and electrical safety standards (CDRH Standard 21 CFR 1040 and UL/IEC 60601-1), which are regulatory compliance standards, not clinical performance acceptance criteria.
Based on the provided text, I cannot answer the questions regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on regulatory clearance through substantial equivalence, comparing the new device to existing predicate devices based on intended use, operating principles, and design aspects.
{0}------------------------------------------------
Image /page/0/Picture/1 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 made up of a solid black shape on the left and a series of horizontal lines on the right.
JUN 1 3 2005
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Family of Pulsed Dye Lasers which is substantially equivalent to previously marketed devices indicted for the following uses:
General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment 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, striae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented Lesions. Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
| Submitted by: | Candela Corporation530 Boston Post RoadWayland, MA 01778-1886 |
|---|---|
| Contact Person: | Lorraine Calzetta |
| Date prepared: | March 11, 2005 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for usein General and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, Candela Family of Pulse Dye Laser SystemsPredicate Devices:Candela Family of Pulsed Dye Lasers - K043251Cynosure VStar (Tristar PDL) - K033176, K032565 |
Description:
The Candela Family of Pulsed Dye Laser Systems are 585, 595nm flash-lamp excited pulse dye medical lasers, indicated for the following uses:
General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
13 p. 1052
{1}------------------------------------------------
Image /page/1/Picture/1 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. The word "CANDELA" is in a simple, sans-serif font.
Summary cont.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as Dormatorogy I hanto Baasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, Poikiloderma of Civate, and benign cutaneous lesions, such as warts, scars, atriae and psoriasis and the treatment of wrinkles. Treatment of Benign Epidermal Pigmented lesions. Treatment of Inflammatory Acne Vulgaris I regilented learning - Treation of benign cutaneous lesions and benign vascular lesions in gynecology. Podiatry: Treatment of benign cutaneous lesions, such as warts.
The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 3, 7 or 10, 12 or 3x10 millimeters on the skin..
The Candela Family of Pulsed Dye Laser Systems is equipped with safety interlock systems to The Canationts and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.
Testing:
As a laser product, the Candela Family of Pulsed Dye Laser Systems conforms to the CDRH I is a laser produce Standard (21 CFR 1040). In addition the laser conforms to UL/IEC 60601-1. Electrical Safety Standard.
Summary of Substantial Equivalence:
The Candela Family of Pulsed Dye Laser Systems, has the same intended use, utilizes similar operating principles and matches key design aspects, as the predicate devices.
On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela Corporation believes that its Candela Family of Pulsed Dye Laser Systems is substantially equivalent to the predicate devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2005
Ms. Lorraine Calzetta Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
Re: K050673
Trade/Device Name: Candela Family of Pulsed Dye Laser Systems 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: March 11, 2005 Received: March 15, 2005
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.
{3}------------------------------------------------
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Ech
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): KO50673
Device Name: Candela Family of Pulsed Dye Laser Systems
Indications For Use:
The Candela Family of Pulse Dye Laser Systems is indicated for the following uses :
General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial Demilatologyn lastic Ourgery. Or treatine, hemangiomas, angioma, spider angioma, and leg telangicolasia, rosaooa, port utaneous lesions, such as warts, scars, striae and Politionermia of Orvate, and bonigh Saturest of Benign Epidermal Pigmented Lesions.
Treatment of Inflammatory Acne Vulgaris
Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.
Podiatry: Treatment of benign cutaneous lesions, such as warts.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qle
Page 1 of
01
§ 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.