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Intended Use. For use in oral/dental procedures for the incision, ablation, vaporization and hemostasis of soft tissue.

Specific Indications for Use:

1. Gingivoplasties
2. Ginaivectomies
3. Frenectomies
4. Benign and malignant lesion removal
5. Biopsies
6. Leukoplakia
7. Fibrotomy

Pharos Optics, Inc. offers a dental laser system known as the FutureLase zooo/goo2 Erbiurm Laser System. The device utilizes laser radiation energy produced at a frequency of 2.94น. This laser system is intended for intraoral or dental soft tissue surgery including the marginal and interdental gingiva. The FutureLase zooo/zoo2 Erbium Laser System is used to assist the dentist or oral surgeon with the following general intended use and/or specific indications for use:

The provided text does not contain information about the acceptance criteria and the study that proves the device meets them in the context of performance metrics like sensitivity, specificity, or accuracy. This document, a 510(k) premarket notification for the FutureLase 3000/3002 Erbium Laser System, is focused on demonstrating substantial equivalence to legally marketed predicate devices.

The information primarily discusses:

• Device Name and Classification: FutureLase 3000/3002 Erbium Laser System, Class II, Product Code 79GEX.
• Intended Use and Specific Indications for Use: For oral/dental procedures involving incision, ablation, vaporization, and hemostasis of soft tissue, including gingivoplasties, gingivectomies, frenectomies, benign/malignant lesion removal, biopsies, leukoplakia, and fibrotomy.
• Device Description: Details on the laser head, power supply, cooling system, control system, control panel, and beam delivery.
• Substantial Equivalence: A comparison table showing that the FutureLase 3000/3002 has similar technical specifications (Laser Type, Wavelength, Pulse Rate, Pulse Duration, Max Pulse Energy, Power, Beam Delivery, Fiber Material, Electrical Requirements, and Indications) to predicate devices (TriLase 2940 Erbium Laser System, MedLite Erbium Laser System, and PulseMaster™ Dental Laser System).

Missing Information:

The document does not include:

1. A table of acceptance criteria and reported device performance related to specific clinical outcomes or statistical metrics.
2. Sample sizes for test sets, their provenance, or whether the study was retrospective or prospective.
3. The number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Results of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
6. Results of standalone (algorithm-only) performance studies.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is typical for a 510(k) submission, where the primary objective is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than to prove absolute safety and effectiveness through extensive clinical trials with specific performance endpoints. The equivalence is primarily established through technical characteristics and similar intended use.

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The Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The Dermablate laser is an erbium: YAG laser operating at 2.94 microns and with a maximum pulse energy of 2 J.

The provided text describes a 510(k) summary for the DERMABLATE ERBIUM LASER SYSTEM. It explicitly states that no performance data, acceptance criteria, or studies were required for this device.

Here's why, based on the provided text:

• The summary in section {1} states: "None. The specifications and intended uses of the Dermablate laser are the Performance Data: same or very similar to those of the claimed predicate devices, including the MCL 29 Dermablate. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

Therefore, I cannot populate the requested information regarding acceptance criteria and studies. The device's clearance was based on its substantial equivalence to legally marketed predicate devices without the need for new performance testing.

Ask a specific question about this device