(31 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 intended use, device description, or other sections. The performance studies focus on laser and electrical safety standards, not AI/ML performance metrics.
Yes.
The device is used for treating various medical conditions such as benign cutaneous vascular lesions, telangiectasia, rosacea, port wine stains, hemangiomas, warts, scars, striae, psoriasis, and periocular wrinkles. "Treatment" implies a therapeutic intent.
No
This device is a therapeutic laser used for treating various benign cutaneous and vascular lesions, not for diagnosing conditions. Its purpose is to deliver energy for treatment, not to analyze or identify medical states.
No
The device description clearly describes a physical laser system with hardware components including a laser, handpiece, optical fiber, and cryogen delivery system, controlled by an embedded microprocessor.
Based on the provided information, the Candela Clearbeam 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 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 Candela Clearbeam Pulse Dye Laser is a medical laser used for treating various skin conditions and lesions directly on the patient's body. It applies 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 Clearbeam 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 Clearbeam 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 lesion, such as warts, scars, striea and psoriasis. Treatment of periocular wrinkles.
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 Clearbeam Pulse Dye laser is a 585 nm pulsed, flash lamp excited dye, medical laser, controlled by an embedded microprocessor, to be used for the treatment of psoriasis, telangiectasia, port wine stains, benign cutaneous lesions and other dermatologic applications. The laser system 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 Clearbeam Pulse Dye Lasers are 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
Not Found
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 Clearbeam Pulse Dye Laser is required to conform and will conform to the Laser Performance Standard (21 CFR 1040). In addition the device will conform 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 Clearbeam 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 devices. On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Candela Clearbeam Laser System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Candela SPTL-1e Pulse Dye Laser (K011092), SLS Biophile Ltd NLite (K000811)
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 "CANDELA" in a stylized font. To the left of the text is a geometric shape that resembles a stylized flame or leaf. Above and to the right of the text, the date "OCT 1 1 2001" is printed in a simple, sans-serif font. The overall impression is of a corporate logo with an associated date, possibly indicating the company's founding or a significant event.
K 013043
510(k) Summary
General Information:
This 510(k) is to provide notification of substantial equivalence for the Candela Clearbeam Pulse This 5 rotty is to to may is substantially equivalent to previously marketed devices intended for Dyo casor Sytiens, film, fi hinneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma, spider angioma, poikiloderma of Civatee and benign cutaneous lesion, such as warts, scars, striea and psoriasis. Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology. Treatment of wrinkles.
| Submitted by: | Candela Corporation
530 Boston Post Road
Wayland, MA 01778-1886 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joan M. Clifford |
| Date prepared: | August 3, 2001 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in
General and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, Clearbeam Pulse Dye Laser System |
| Predicate Devices: | Candela SPTL-1e Pulse Dye Laser (K011092), SLS Biophile
Ltd NLite (K000811) |
Description:
The Clearbeam Pulse Dye laser is a 585 nm pulsed, flash lamp excited dye, medical laser, controlled by an embedded microprocessor, to be used for the treatment of psoriasis, telangiectasia, port wine stains, benign cutaneous lesions and other dermatologic applications. The laser system 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 Clearbeam Pulse Dye Lasers are 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.
Testing:
As a laser product, the Clearbeam Pulse Dye Laser is required to conform and will conform to the Laser Performance Standard (21 CFR 1040). In addition the device will conform 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:
1
Summary of Substantial Equivalence:
The Candela Clearbeam 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 devices.
On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Candela Clearbeam Laser System 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol features a staff with a snake winding around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2001
Candella Corporation c/o Mr. Donald J. Sherratt Medical Stream Director Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01779
Re: K013043
Trade/Device Name: Candela Clearbeam Pulse Dye Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 27, 2001 Received: September 28, 2001
Dear Mr. Sherratt :
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 - Mr. Donald J. Sherratt
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iction with and w you to over finding of substantial equivalence of your device to a legally premaired 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 and 11 you desire specific arrast 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 1 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mistmation the mational 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,
Susan Walker, MD
Image /page/3/Picture/5 description: The image contains a handwritten signature or initial. The signature appears to be cursive and is written in black ink. The writing is stylized and difficult to decipher without additional context.
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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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 black and has horizontal lines running through it. The word "CANDELA" is in a simple, sans-serif font.
510(k) Number (if known): __ K 0 | 3 0 4 3
Device Name: Candela Clearbeam Pulse Dye Laser System
Indications For Use:
The Candela Clearbeam 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 lesion, such as warts, scars, striea and psoriasis. Treatment of periocular wrinkles.
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)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K013043 |
| Prescription Use_ (Per 21 CFR 801.109) | |
|---|---|
| ---------------------------------------- | -- |
OR
| Over-The-Counter Use_ | |
|---|---|
| ----------------------- | -- |
(Optional format 1-2-96)