(185 days)
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Not Found
No
The device description focuses on traditional laser technology components and a microprocessor-based system controller for user input, with no mention of AI or ML capabilities.
Yes
The device is intended for "treatment of pigmented lesions and tattoos," which indicates a therapeutic purpose.
No
The device is described as being "intended for use in the treatment of pigmented lesions and tattoos," indicating a therapeutic rather than a diagnostic purpose. The description focuses on energy emission and delivery for treatment, with no mention of assessing, identifying, or analyzing medical conditions.
No
The device description clearly outlines multiple hardware components including a laser head, power supply, circulator system, and optical delivery system, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the treatment of pigmented lesions and tattoos." This describes a therapeutic or cosmetic treatment applied directly to the patient's body.
- Device Description: The description details a laser system that emits energy to target tissue. This is consistent with a therapeutic device, not a device used to examine samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used for direct treatment.
N/A
Intended Use / Indications for Use
"for use in the treatment of pigmented lesions and tattoos."
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
"The Candela Q-Switched Alexandrite Lasers utilize an alexandrite rod (crystal) which emits pulsed energy at 755 nm in the near-infrared region of the electromagnetic spectrum. An electro-optical Q-Switch is employed to control pulse duration. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Q-Switched Alexandrite Lasers are designed with five major components: - the high voltage power supply and modulator system; 1) - 2) the optical laser head; - 3) the circulator system; - 4) the microprocessor-based system controller and user display panel; - 5) the optical delivery system. The Candela Q-Switched Alexandrite Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an on-board control panel to regulate operation during treatment."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"Testing of the Candela Q-Switched Alexandrite Lasers consist of component testing and functional testing of the completed laser."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 (Models PLTL-1 and TL-1), Cynosure Photogenica T10 Tattoo Removal Laser
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.
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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
K 955662
510(k) SUMMARY
14 1996
General Information
This premarket notification is for the Candela Q-Switched Alexandrite Lasers intended for use in the treatment of pigmented lesions and tattoos.
| Classification: | Class II (21 CFR 878.4810 Laser Surgical Instrument for use in General and Plastic
Surgery and in Dermatology) |
|-------------------|-------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dermatology Laser, Q-Switched Alexandrite Laser |
| Predicate Device: | Candela Q-Switched Alexandrite Laser (Models PLTL-1 and TL-1)
Cynosure Photogenica T10 Tattoo Removal Laser |
Description
The Candela Q-Switched Alexandrite Lasers utilize an alexandrite rod (crystal) which emits pulsed energy at 755 nm in the near-infrared region of the electromagnetic spectrum. An electro-optical Q-Switch is employed to control pulse duration. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Q-Switched Alexandrite Lasers are designed with five major components:
- the high voltage power supply and modulator system; 1)
-
- the optical laser head;
-
- the circulator system;
-
- the microprocessor-based system controller and user display panel;
-
- the optical delivery system.
The Candela Q-Switched Alexandrite Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an on-board control panel to regulate operation during treatment.
Product Development Review
Design reviews conducted during development of this device verify the appropriateness of materials and design selection.
Testing
Testing of the Candela Q-Switched Alexandrite Lasers consist of component testing and functional testing of the completed laser.
Summary of Substantial Equivalence
On the basis of similarities in principles of operation, design, materials, source of energy, methods of assembly, and intended use, Candela has determined that its Q-Switched Alexandrite Lasers are substantially equivalent to the above referenced predicate devices.
No new questions of safety and efficacy are raised by the introduction of this device into commercial distribution.