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K Number
K963389
Device Name
FLEX-LASE 600 SERIES ION LASER SYSTEM
Manufacturer
AMERICAN LASER MEDICAL
Date Cleared
1996-11-26

(90 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K913428,K913569,K903883
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Flaxelase 600 Series Ion Laser is intended for use in the treatment of selected yascular and pigmented lesions of the skin. Laser light of a selected wavelength is used to photocoagulate tissue based on the absorption characteristic of the targeted chromophore within the tissue.

Flex-Lase 600 Ion Laser is intended for use in the the a treatment of salected pigmented and vascularized lesions of the skin. Representative indications for use are:

Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm)

  1. Capillary Hemangioma (port wine hemangioma)
  2. Strawberry hemangioma
  3. Telangectasia
  4. Rosacea

For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm).

  1. Freckles
  2. Age Spots
  3. Cafe-au-lait
  4. Lentigo

Flex-Lase Model 620 Laser System For Wascular Sesions: (Blue/Green - 488 nm and 514.5 nm)

  1. Capillary Hemangioma (port wine hemangioma)
  2. Strawberry Hemangioma
  3. Telangectasia
  4. Rosagea .

For pigmented lesions: (Green - p14.5 mm)

  1. Freckles
  2. Age Spots
  3. Cafe-Au-Lait
  4. Lentigo
Device Description

The Flex-Lase 600 Series Ion Laser submission covers all of the internal parts, subassemblies and components as well as the completed device. The Flex-Lase Model 640 is a coninuous wave krypton laser system emitting light at the 568 nm (yellow) and 520/530 nm (green) wavelengths. The Flex-Lase Model 620 is a continuous wave argon laser system emitting light at the 488 nm (blue) and the 514 nm (green) wavelengths.

Treatment beam output for the Flex-Lase Model 640 (krypton) is 1.0 Watt (yellow) and 3.0 Watts (yellow-green simultaneous). The power output for the Flex-Lase Model 620 (argon) is 5.5 watts blue-green or 2.0 watts green. The aiming beam is provided by an adjustable intensity incoherent white light source. Exposure times for the Flex-Lase 600 Series Ion Laser (in seconds) are 0.02, 0.05, 0.1. 0.25, 0.5, 1.0, and continuous.

Laser activation occurs by footswitch. Overall weight of the system is 112 lbs. (51 kg). The Flex-Lase 600 Series Ion Laser has a footprint of 16 X 24 inches (38 X 60 cm) and is 36 inches (90 cm) high.

The electrical power requirement is 208 VAC 40 amb single phase. Cooling is provided by external filtered flow-through tap water at a minimum rate of 2.5 gallons (9,5 liters) per minute.

Accessories available for use with the Flex-lase 600 Ton Laser include a fooysing handpiece with interchangeable guide tips and/or the Hexascan Mark II. The Flex-laser 600 series is not a computer controlled device.

AI/ML Overview

The provided text describes a medical device, the Flex-Lase 600 Series Ion Laser, and asserts its substantial equivalence to other commercially available lasers for treating vascular and pigmented lesions. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This is a regulatory pathway where a new device is shown to be as safe and effective as a legally marketed predicate device, rather than undergoing a de novo clinical trial with specific performance endpoints.

Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be extracted from the provided text.

Here's a breakdown of what can be inferred from the document regarding its regulatory submission and what cannot be answered:

1. A table of acceptance criteria and the reported device performance:

  • Cannot be extracted. The document does not describe specific acceptance criteria (e.g., a target accuracy rate, sensitivity, specificity, or precision) for the Flex-Lase 600 Series Ion Laser itself, nor does it report performance metrics against such criteria. The "performance" described is in comparison to predicate devices, focusing on technical specifications rather than clinical outcomes with quantified performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

  • Cannot be extracted. Since there is no described study with acceptance criteria, there is no mention of a test set, sample size, or data provenance from a performance study. The "data" provided is a comparison of technical features between the Flex-Lase and predicate devices.

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):

  • Cannot be extracted. Ground truth establishment is irrelevant in this context, as there is no performance study against a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Cannot be extracted. Adjudication methods are relevant for clinical performance studies, which are not detailed in this 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:

  • Cannot be extracted. The device is a laser system, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study and AI performance improvement are not applicable to the information provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

  • Cannot be extracted. This question is also not applicable as the device is a medical laser, not an algorithm. The document describes the specifications and intended use of a physical laser device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • Cannot be extracted. As there is no described performance study, there's no mention of ground truth. The "proof" of safety and effectiveness relies on comparison to predicate devices.

8. The sample size for the training set:

  • Cannot be extracted. There is no training set mentioned because this is not an AI/machine learning device requiring training data.

9. How the ground truth for the training set was established:

  • Cannot be extracted. Not applicable, as there is no training set for this type of device.

What the document does describe (relevant to regulatory submission):

The document effectively fulfills the requirements for a 510(k) Pre-market Notification by demonstrating substantial equivalence to predicate devices. Key aspects of this demonstration include:

  • Comparison of Device Characteristics: Extensive tables (pages 4-7) compare various technical specifications of the Flex-Lase models (620 and 640) with several predicate devices (HGM K1, Metalaser Vasculase, Coherent Artisan). These characteristics include:
    • Type of laser (Continuous wave argon/krypton, Copper Vapor)
    • Wavelength
    • Exposure Time
    • Output Mode
    • Beam Delivery
    • Stability of Output Energy
    • Spot Size
    • Energy density
    • Aiming beam
    • Cooling
    • Electrical Requirements
    • Indications for Vascular Lesions
    • Indications for Pigmented Lesions
  • Statement of Substantial Equivalence: The document explicitly states that the Flex-Lase 600 Series Ion Laser "is substantially equivalent" to the named predicate devices for both vascular and pigmented lesions based on "materials, intended use, method of manufacture, design, precautions, cautions, and treatment parameters" being "substantially the same."
  • Predicate Device K Numbers: K-numbers for some predicate devices (HGM K1: K913428, K913569; Metalaser Vasculase: K903883) are provided, which is typical for substantial equivalence claims.

In conclusion, the document provides information for a regulatory clearance based on substantial equivalence, not a performance study against specific acceptance criteria.

§ 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.