(75 days)
Not Found
No
The device description details a laser system with a microprocessor controller for managing system functions and user-selected parameters. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies.
Yes
The device is indicated for specific medical uses (pigmented lesions and tattoos) and is intended for "Prescription Use," which are characteristics of a therapeutic device.
No
Explanation: The device description and intended uses clearly describe a laser system designed for treatment (tattoo and pigmented lesion removal) and not for diagnosing medical conditions.
No
The device description explicitly details hardware components such as a laser head, power supply, water circulator, optical fiber, and handpiece. The software component (microprocessor-based system controller) is described as controlling these hardware functions, not as a standalone medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for "Pigmented Lesions" and "Tattoos." These are treatments performed directly on a patient's body, not tests performed on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a laser system designed to deliver energy to a treatment area on a patient. It describes components like a laser head, optical fiber, and handpiece, all consistent with a therapeutic or cosmetic device used externally on the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes related to diagnosing conditions based on in vitro analysis.
Therefore, the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is a therapeutic or cosmetic laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for the following uses:
Pigmented Lesions Tattoos
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consists of an Alexandrite laser head, a Q-switching mechanism, a power supply and a deionized water circulator. The laser head contains the cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the contril bronnel. which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is fully air cooled.
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm with a nominal pulse width of 50 nanoseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.
A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems supports 2mm, 3mm, and 4mm nominal spot sizes.
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)
Not Found
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.
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.
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Image /page/0/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 on the left side and has horizontal lines on the right side. The word "CANDELA" is in a simple, sans-serif font.
510(k) Summarv
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 100k) summary have been provided in conformance with 21 CFR §807.92.
Submitter Information
| Company Name: | Candela Corporation | DEC 20 2006 |
|---|---|---|
| Company Address: | 530 Boston Post Road | |
| Wayland, MA 01778 | ||
| Company Phone: | 508-358-7400 | |
| Company Facsimile: | 508-358-5602 | |
| Contact Person: | Mr. Jeffrey Roberts | |
| Manager, Regulatory Affairs | ||
| Date summary Prepared: | 10/05/06 | |
| Device Identification |
Device Trade/Proprietary Name: The Candela Family of Q-Switched Alexandrite Laser
| (AlexLAZR) systems | ||
|---|---|---|
| Common Name: | Q-Switched Alexandrite Laser | |
| Classification Name: | Laser Surgical Instrument, for use in General and Plastic | |
| Surgery and Dermatology | ||
| Classification Regulation: | 21 CFR § 878.4810 | |
| Device Classification: | II |
Identification of Predicate Device
| Predicate Device(s): | Candela Q-Switched Alexandrite Laser (AlexLAZR), K955662 |
|---|---|
| Candela Q-Switched Alexandrite Laser (AlexLAZR), K950831 |
Device Description
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consists of an Alexandrite laser head, a Q-switching mechanism, a power supply and a deionized water circulator. The laser head contains the cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the contril bronnel. which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is fully air cooled.
1
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm with a nominal pulse width of 50 nanoseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.
A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems supports 2mm, 3mm, and 4mm nominal spot sizes.
Description of Intended Use
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for treatment in the following uses:
Pigmented Lesions Tattoos
Rationale for Substantial Equivalence
The Candela Family of O-Switched Alexandrite Laser (Alexi.AZR) systems, has the same intended use, utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system) , as the predicate devices.
The Candela Family of Q-Switched Alexandrite Laser (Alex) systems shares similar methods of assembly, method of operation, and intended uses, and therefore is substantially equivalent to the currently legally marketed Candela Q-Switched Alexandrite Laser, (AlexLAZR), K955662, Candela Q-Switched Alexandrite Laser (AlexLAZR), K95083 predicate devices.
Safety and Effectiveness Information
The Candela Family of Q-Switched Alexandrite Laser (Alex(AZR) systems is substantial equivalent to the currently legally marketed Candela O-Switched Alexandrite Laser, (AlexyAZR), K955662, Candela Q-Switched Alexandrite Laser (AlexiAZR), K950831 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the Candela Family of Q-Switched Alexandrite Laser (Alex147R) systems
Conclusion
Base on the similarities in indications for use, design features, and functional features the Candela Family of O-Switched Alexandrite Laser (Alex(AZR) systems has been shown to be substantially equivalent to the current legally marketed predicate devices.
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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 stylized caduceus, which is a symbol of medicine, with a single snake entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2006
Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778
Re: K063073
Trade/Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) 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: October 5, 2006 Received: October 10, 2006
Dear Mr. Roberts:
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
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Page 2 - Mr. Jeffrey Roberts
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.
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 premained nevice 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely, yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K063073
Device Name: Candela Family of Q-Switched Alexandrite Leser (AlexyAzB) systems
Indications for Use:
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for the following uses:
Pigmented Lesions Tattoos
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NELDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 4663073 |
|---|---|
| --------------- | --------- |
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