(36 days)
Not Found
No
The description details a laser system with a microprocessor for controlling system functions based on user-selected parameters. There is no mention of AI or ML for image processing, data analysis, or automated decision-making.
Yes
The device is indicated for treating "Pigmented Lesions" and "Tattoos", which are medical conditions or characteristics, thus making it a therapeutic device.
No
The device description and intended use indicate that the Candela Q-Switched Alexandrite Laser is used for treatment (pigmented lesions, tattoos) by delivering laser energy, not for diagnosis.
No
The device description clearly outlines significant hardware components including a laser head, power supply, water circulator, optical fiber, and handpiece. 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 information, 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 conditions treated directly on the patient's body.
- Device Description: The description details a laser system designed to deliver energy to the skin for treatment. 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 the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples taken from the body to provide diagnostic information. This device is a therapeutic laser used for direct treatment of skin conditions.
N/A
Intended Use / Indications for Use
The Candela Family of Q-Switched Alexandrite Lasers are 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 Q-Switched Alexandrite Laser consists of an Alexandrite laser head, power supply and deionized water circulator The laser head contains 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 Candela Q-Switched Alexandrite Laser delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. When the Q-switching mechanism is disabled the system has the capability of producing a laser pulse duration of 0.050 - 0.120 milliseconds. 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 Q-Switched Alexandrite Laser supports 2mm, 3mm, and 5mm 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, K073534, Candela 3630 Laser System (Alexandrite) K063074, Cynosure Accolade Elite Laser (Alexandrite) K072868
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/1 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 made up of several horizontal lines, and the word "CANDELA" is written in a simple, sans-serif font.
510(k) Summary
JUN 1 7 2008
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 |
|---|---|
| Company Address: | 530 Boston Post Road |
| Wayland, MA 01778 | |
| Company Phone: | 508-358-7400 |
| Company Facsimile: | 508-358-5602 |
| Contact Person: | Lisa LaCroix |
| Senior Regulatory Affairs Specialist | |
| Date summary Prepared: | May 9, 2008 |
| Device Identification | |
| Device Trade/Proprietary Name: | The Candela Family of Q-Switched Alexandrite |
| Lasers | |
| Common Name: | Q-Switched Alexandrite Laser |
Classification Name: Laser Surgical Instrument, for use in General and Plastic Surgery and Dermatology Classification Requlation: 21 CFR § 878.4810 Device Classification: =
ldentification of Predicate Device
| Predicate Device(s): | Candela Q-Switched Alexandrite Laser, K073534 |
|---|---|
| Candela 3630 Laser System (Alexandrite) K063074 | |
| Cynosure Accolade Elite Laser (Alexandrite) K072868 |
Device Description
The Candela Q-Switched Alexandrite Laser consists of an Alexandrite laser head, power supply and deionized water circulator The laser head contains 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 Candela Q-Switched Alexandrite Laser delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. When the Q-switching mechanism is disabled the system has the capability of producing a laser pulse duration of 0.050 - 0.120 milliseconds. 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
1
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 Q-Switched Alexandrite Laser supports 2mm, 3mm, and 5mm nominal spot sizes.
Description of Intended Use
The Candela Family of Q-Switched Alexandrite Lasers are indicated for treatment in the following uses:
Pigmented Lesions Tattoos
Rationale for Substantial Equivalence
The Candela Q-Switched Alexandrite Laser 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 Q-Switched Alexandrite Laser 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 K073534, Candela 3630 Laser Systems, Alexandrite, K063074 and Cynosure Apogee Elite Laser, Alexandrite, K034030 predicate devices.
Safety and Effectiveness Information
Candela believes that there are no new questions of safety or effectiveness raised and the Candela Q-Switched Alexandrite Laser is substantially equivalent to the current legally marketed Candela Q-Switched Alexandrite Laser, K073534, Candela 3630 Laser System (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.
Conclusion
Based on the similarities in indications for use, design features, and functional features, the Candela Q-Switched Alexandrite Laser 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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Candela Corporation % Ms. Lisa LaCroix Senior Regulatory Affairs Specialist 530 Boston Post Road Wayland, Massachusetts 01778
Re: K081324
Trade/Device Name: Candela O-Switched Alexandrite Laser 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: June 9, 2008 Received: June 10, 2008
JUN 1 7 2008
Dear Ms. LaCroix:
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 - Ms. Lisa LaCroix
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 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. Millican
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 Statement
510(k) Number (if known): __
Device Name: Candela Q-Switched Alexandrite Laser
Indications for Use:
The Candela Q-Switched Alexandrite Laser is indicated for the following uses:
Pigmented Lesions Tattoos
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nelle Ogl for man
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K081324
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