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K Number
K994260
Device Name
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
Manufacturer
CANDELA CORP.
Date Cleared
2000-05-26

(161 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K974381,K981351,K982940,K980517,K990903
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Candela GentleLASE GL Dermatology Laser is indicated for the following uses :

  1. The Photocoagulation of Dermatological vascular lesions.
  2. Temporary hair reduction.
  3. Stable long-term, or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. It is also intended for the photocoagulation of dermatological vascular lesions.
Device Description

The Candela (Modified) GentleLASE GL Laser utilizes 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 Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela GentleLASE Lasers are designed with six major components:

  1. High voltage power supply and modulator system
  2. Optical laser head
  3. Circulator system
  4. Optical delivery system
  5. Software control system
  6. Dynamic cooling device
    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.
AI/ML Overview

The provided text is a 510(k) Summary for the Candela GentleLASE GL Laser System. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's technical specifications and intended uses.

Crucially, the document explicitly states: "A clinical trial demonstrated that the GentleLASE Laser System removes unwanted hair without raising any unexpected safety issues." However, beyond this high-level statement, the document does NOT provide detailed information about the acceptance criteria, specific performance metrics, or the study design requested in the prompt.

Therefore, I cannot extract the specific information about acceptance criteria and the study that proves the device meets them from the provided text. The document is a regulatory submission for substantial equivalence, not a detailed clinical study report.

Based on the provided text, I can only state the following:

  1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only states, "A clinical trial demonstrated that the GentleLASE Laser System removes unwanted hair without raising any unexpected safety issues." No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, hair count reduction percentages, etc.) are listed.
  2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not provided in the document.
  4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the document.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system for dermatology, not an AI-assisted diagnostic tool that would involve "human readers."
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an "algorithm only" component in the sense of AI diagnostics. Its performance is directly tied to the physical application of laser energy by a human operator.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but it would presumably be clinical outcomes data related to hair reduction and safety observations.
  8. The sample size for the training set: Not applicable and not provided. The device is a physical laser system, not a machine learning algorithm.
  9. How the ground truth for the training set was established: Not applicable and not provided. The device is a physical laser system, not a machine learning algorithm.

§ 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.