(92 days)
Not Found
No
The device description mentions an "embedded microprocessor" for control, but there is no mention of AI, ML, or related terms in the provided text. The focus is on the laser technology and safety features.
Yes
The device is indicated for the treatment of various medical conditions, including benign cutaneous vascular lesions, benign cutaneous lesions, wrinkles, and inflammatory acne vulgaris. These treatments involve directly affecting the structure or function of the body, which aligns with the definition of a therapeutic device.
No
The device description and intended use clearly state that the Candela Cbeam Pulse Dye Laser is used for "treatment" (e.g., photocoagulation, treatment of wrinkles, treatment of inflammatory acne vulgaris of various conditions), not for diagnosis.
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 Cbeam Pulse Dye Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening.
- Candela Cbeam Function: The description clearly states that the Candela Cbeam is a laser used for photocoagulation and treatment of various cutaneous and vascular lesions directly on the patient's body. It delivers energy to the skin and underlying tissues.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient.
Therefore, the Candela Cbeam Pulse Dye Laser falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous (skin)
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Candela Cbeam Pulse Dye Laser (K020958), ICN Photonics NLite (K024189)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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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
OR
Prescription Use X (Pcr 21 CFR 801.109) Over-The-Counter Use
(Optional format 1-2-96)