(133 days)
The Candela Gentlelase GL Dermatology Vascular Lesion Laser is used for the photocoagulation of dermatological vascular lesions.
The Candela Gentlelase GL Lasers utilize an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with four major components:
- High voltage power supply and modulator system
- Optical laser head
- Circulator system
- Optical delivery system
The Candela Gentlelase 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.
The Candela Gentlelase GL Laser System submission (K972767) is a 510(k) for a medical device, which seeks to demonstrate substantial equivalence to a predicate device rather than fulfilling specific, quantifiable acceptance criteria through clinical studies. Therefore, the information typically requested for AI/algorithm-driven device acceptance and studies involving ground truth and expert reviews is not directly applicable in this context.
Here's a breakdown of the information as it relates to K972767:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Same intended use as predicate devices. | Used for the photocoagulation of dermatological vascular lesions, identical to the predicate device. |
| Operating Principles Equivalence: Utilizes the same operating principles as predicate devices. | Utilizes an Alexandrite rod emitting pulsed energy at 755 nm, consistent with predicate devices. |
| Design Aspects Equivalence: Matches key design aspects (e.g., spot size, wavelength, max delivered power) of the predicate device. | Same wavelength (755 nm) and same maximum delivered power as the predicate device (Cynosure Photogenica LP Laser). Similar spot size to the predicate. |
| Safety: Equipped with safety interlock systems to protect patients and operators. | Device is equipped with safety interlock systems. (This is a design feature, not a performance metric from a clinical trial). |
| Functional Equivalence: Performs its intended function reliably. | Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser. (No specific performance metrics are provided in the summary, implied by successful functional testing). |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable for this type of submission. This 510(k) submission does not describe a clinical study with a "test set" in the context of an algorithm or diagnostic device. The "testing" mentioned refers to component and functional engineering tests of the laser system itself, not performance evaluation on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There was no "test set" and no ground truth established by experts in the context of a diagnostic or AI performance study.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is not relevant for this type of device (a therapeutic laser) seeking substantial equivalence based on physical and functional similarities to a predicate device, rather than diagnostic accuracy or human-AI interaction.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a therapeutic laser device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. There was no "ground truth" used in the context of a diagnostic or AI performance study. The primary "ground truth" or basis for acceptance in a 510(k) for a therapeutic device like this is demonstrating physical and functional equivalence to a legally marketed predicate device, along with verification through engineering and functional testing.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI/algorithm-driven device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
Summary of the Study (or Basis for Clearance):
The "study" in this context is the submission's argument for substantial equivalence to existing predicate devices.
- Basis for Substantial Equivalence: Candela asserted that its Gentlelase GL Laser System is substantially equivalent to the Cynosure Photogenica LP Laser (cleared on 10/29/96 under K963094) and previously cleared Candela Q-Switched Alexandrite Lasers.
- Key Arguments for Equivalence:
- Identical Intended Use: Photocoagulation of dermatological vascular lesions.
- Same Operating Principles: Both use an Alexandrite rod to emit pulsed energy at 755 nanometers.
- Similar Design Aspects: Matches key design elements like similar spot size, the same wavelength, and the same maximum delivered power as the predicate device.
- Method of Assembly and Operation: Similar to predicate devices.
- Testing Performed: Component testing and functional testing of the completed laser. (Details of these tests are not provided in the summary but would have been part of the full submission).
The FDA reviewed this evidence and determined that the device was substantially equivalent, allowing it to be marketed. The acceptance criteria were implicitly met by demonstrating these similarities and functional performance through engineering tests.
§ 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.