(108 days)
Not Found
No
The description details a laser system with a microprocessor controller for basic system functions and parameter selection, but there is no mention of AI or ML capabilities for image processing, diagnosis, or treatment planning.
Yes
The device is indicated for treating pigmented lesions and tattoos, which are conditions addressed for medical or aesthetic improvement, thus qualifying it as a therapeutic device.
No
Explanation: The device description and intended use clearly state that this is a laser system used for treating pigmented lesions and tattoos, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a laser head, power supply, water circulator, optical fiber, handpiece, and flashlamps. While it mentions a microprocessor-based system controller, the core functionality and delivery of treatment are dependent on the physical laser system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are "Pigmented Lesions" and "Tattoos." These are clinical treatments performed directly on a patient's body.
- Device Description: The description details a laser system designed to deliver energy to the skin for therapeutic purposes. It describes components like a laser head, power supply, optical fiber, and handpiece, all indicative of a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition. The device's function is to interact with the patient's body directly.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for treatment in 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 consist of an Alexandrite laser head, power supply and deionized water circulator. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems also contains a Q-switching mechanism which when disabled allows the laser system the capability of producing a laser pulse duration of 0.050 - 0.120 millisecond. 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 control panel, 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 laser system is fully air cooled.
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. 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 support 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.
Candela Q-Switched Alexandrite Laser, (AlexLAZR), K063073, Candela 3630 Laser Systems, Alexandrite, K063074, Cynosure Apogee Elite Laser, Alexandrite, K034030
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
Image /page/0/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame symbol on the left and the word "CANDELA" in capital letters on the right. The flame symbol is black and has horizontal lines in the lower right portion.
Ko73534
Page 1 of 2
510(k) Summary
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 510(k) summary have been provided in conformance with 21 CFR $807.92.
Submitter Information
| Company Name: | Candela Corporation | APR - 3 2008 |
|---|---|---|
| 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: | 12/12/07 |
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), K063073
Candela 3630 Laser Systems, Alexandrite, K063074
Cynosure Apogee Elite Laser, Alexandrite, K034030 |
| ---------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Device Description
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consist of an Alexandrite laser head, power supply and deionized water circulator. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems also contains a Q-switching mechanism which when disabled allows the laser system the capability of producing a laser pulse duration of 0.050 - 0.120 millisecond. 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 control panel, 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 laser system is fully air cooled.
1
0735 24
Page 292
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. 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 support 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 Q-Switched Alexandrite Laser (AlexLAZR) 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 (AlexLAZR) systems shares similar methods of assembly, method of operation, and intended uses, and therefore is substantially equivalent to the current legally marketed Candela Q-Switched Alexandrite Laser, (AlexiAzR), K063073, Candela 3630 Laser Systems, Alexandrite, K063074 and Cynosure Apogee Elite Laser, Alexandrite, K034030 predicate devices.
Safety and Effectiveness Information
The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is substantially equivalent to the current legally marketed Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) Systems, K063073, Candela 3630 Laser Systems, Alexandrite, K063074, and Cynosure Apogee Elite Laser, Alexandrite, K034030 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 (Alex1,AZR) systems
Conclusion
Base on the similarities in indications for use, design features, and functional features the Candela Family of Q-Switched Alexandrite Laser (Alex147R) systems has been shown to be substantially equivalent to the current legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with outstretched arms. The symbol is composed of three curved lines that converge at the center.
Public Health Service
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Candela Corporation % Mr. Jeffrey Roberts Manager, Regulatory Affairs 530 Boston Post Road Wayland. Massachusetts 01778
APR - 3 2008
Re: K073534
Trade/Device Name: Candela Family of O-Switched Alexandrite (Alexy A7R) systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical Instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 14, 2007 Received: December 17. 2007
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 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. Jeffrey Roberts
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N. Milliman
Mark N. Melkerson 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):
Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Rf Ogle Gormxn
(Division Sign-Off Division of General, Restorative, and Neurological Devices
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510(k) Number K073534