(78 days)
Not Found
No
The device description mentions an "embedded microprocessor" for control, but there is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is described as a medical laser used for treatment of various benign conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device description and intended use clearly state that the Candela Vbeam Pulse Dye Laser is used for treatment purposes, such as photocoagulation of lesions, treatment of wrinkles, and inflammatory acne vulgaris. There is no mention of diagnostic functions.
No
The device description clearly states it is a "flash-lamp excited pulse dye medical laser" and describes physical components like an optical fiber, handpiece, and cryogen delivery system. This indicates it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the Candela Vbeam Pulse Dye Laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended uses clearly state that the Vbeam is a laser used for treating various skin conditions and lesions directly on the patient's body. It delivers energy to the skin for therapeutic purposes.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
Therefore, the Candela Vbeam Pulse Dye Laser is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Candela Vbeam 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.
Product codes
GEX
Device Description
The Vbeam is a 595 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 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, for the treatment of wrinkles and the treatment of inflammatory acne vulgaris.. The Vbeam 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 Vbeam 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the Candela logo with the text "Cbeam 510k Summary" at the top right. The date "JAN 1 6 2004" is printed above the Candela logo. The logo consists of a stylized flame-like shape on the left and the word "CANDELA" in bold, sans-serif font on the right.
KD33461 1 of 2
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Vbcam Pulse This JTV(x) is to provision 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 Civates 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 Vbeam Pulse Dye Laser as cleared under K 021180.
| 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, Vbeam Pulse Dye Laser System |
| Predicate Devices: | Candela Vbeam Pulse Dye Laser (K021180), ICN Photonics
NLite (K024189) |
Description:
The Vbeam is a 595 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 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, for the treatment of wrinkles and the treatment of inflammatory acne vulgaris.. The Vbeam 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 Vbeam 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.
8 02
1
Image /page/1/Picture/1 description: The image shows a logo with a stylized flame-like shape on the left and the word "CANDELA" on the right. The flame shape is divided into two sections, with the left section being solid black and the right section consisting of horizontal lines. The word "CANDELA" is written in a simple, sans-serif font, with each letter clearly defined. The logo appears to be for a company or organization named Candela.
K033461 2 of 2
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 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 Vbeam Laser has the same intended use, utilizes similar operating principles and matches key design aspects, including similar spot size, and 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 Vbeam Laser System is substantially equivalent to the predicate device.
8 03
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2004
Ms. Lorraine Calzetta Patrovic Manger, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
Re: K033461
Trade/Device Name: Candela Vbeam Pulsc 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 27, 2003 Received: October 30, 2003
Dear Ms. Patrovic:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the 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 encrosule) (c regars) the enactment date of the Medical Device Amendments, or to conniered price to may 20, 2017 - 11:11 accordance with the provisions of the Federal Food, Drug, devices market Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmete Act (710) that do not required to the general controls provisions of the Act. The r ou may, dicrororo, manes are & Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Spccial Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be subject to subli additions, 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 docs not mean Flease be advised that 1197 5 resuarce or our device complies with other requirements of the Act that I DT has made a contrimalations administered by other Federal agencies. You must of any I edical statutes and regaranchs, including, but not limited to: registration and listing (21 Comply with an the 7ter 51equirements, costs 801); good manufacturing practice requirements as set CITY art 8077, mooning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Scctions 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 Scction 510(k) This letter will anow you to obgin maing of substantial equivalence of your device to a legally premarket notification. The Pira mangssification 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 If you desire specific advise is. Jour 201) 594-4659. Also, please note the regulation entitled, Connect the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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
Indications for Use
510(k) Number (if known): K033461
Device Name: Candela Vbeam Pulse Dye Laser System
Indications For Use:
The Candela Vbeam 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.
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)
Miriam C Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
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K033461 010(k) Number ----------------------------------------------------------------------------------------------------------------------------------------------------------------