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The MLT R694 Ruby Laser System (operating in the Q-Switched mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tatoo removal and treatment of benign pigmented lesions.

The MLT R694 Ruby Laser System is restricted to sale to or use by licensed professionals in the United States

The MLT R694 laser operates as a normal pulse or as a O-Switched rubv laser which emits a beam of coherent light at 694 nanometers. In the Q-Switched mode the beam has a much shorter pulse duration than in the normal or long pulse mode. The specifications for the normal or long pulse mode remain the same as described in K980187.

The provided document, a 510(k) summary for the MLT R694 Ruby Laser System, states that no performance data was required because "The specifications and intended uses of the MLT R694 ruby system laser operating in the Q-Switched mode are the same or very similar to those of the claimed predicate devices." Therefore, no specific acceptance criteria or studies proving the device meets them are detailed in this document.

The submission relies on substantial equivalence to predicate devices. This means that instead of conducting new performance studies, the manufacturer demonstrated that their device is as safe and effective as other legally marketed devices (predicates) with similar characteristics and intended uses.

Based on the provided text, the following information is not available or not applicable:

1. Table of acceptance criteria and reported device performance: Not applicable, as performance data was not required for this 510(k) submission.
2. Sample size used for the test set and the data provenance: Not applicable. No test set was used, as performance data was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring ground truth was used.
4. Adjudication method for the test set: Not applicable. No test set was used.
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, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used: Not applicable. No test set requiring ground truth was used.
8. The sample size for the training set: Not applicable. This device is a laser system, not an AI model requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This device is a laser system, not an AI model.

Summary of available information regarding the justification for market clearance:

• Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.
• Predicate Devices: LaseAway Long Pulse and Q-Switched Ruby Laser, MM-Ruby Laser; Spectrum RD 1200; Candela AlexLAZR.
• Reason for no performance data: The specifications and intended uses of the MLT R694 ruby system laser operating in the Q-Switched mode are the same or very similar to those of the claimed predicate devices.
• Conclusion: The MLT R694 in Q-Switched mode is substantially equivalent to legally marketed predicate devices. The normal mode operation of the MLT R694 (K980187) was already found substantially equivalent and its characteristics are not affected by the Q-Switched modification.

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The M.L.T. 30 CO2 laseris intended for the ablation, vaporization, incision, and or cutting of soft tissue in: Oral surgery, Dermatology, E.N.T., Gynaecology.

The Medical Laser Technologies Ltd. MLT 30 CO2 Laser emits a beam of coherent light at 10.6 microns.

The provided text describes a 510(k) summary for the Medical Laser Technologies Ltd. MLT 30 CO2 Laser. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance data from a new study.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not applicable. No new test set data was generated or used as performance data was not required.
• Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No new test set data was generated or used.

4. Adjudication method for the test set

• Not applicable. No new test set data was generated or used.

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 is a medical device (laser) and not an AI-based diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This is a medical device (laser) and not an AI-based algorithm. No standalone performance study was conducted.

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

• Not applicable. The submission relies on substantial equivalence to a predicate device, not on new clinical performance data with ground truth.

8. The sample size for the training set

• Not applicable. This product is a conventional medical laser, not an AI or machine learning device requiring a training set.

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

• Not applicable.

Summary of Device Acceptance:

The acceptance of the MLT 30 CO2 Laser was based on demonstrating substantial equivalence to a previously legally marketed predicate device (Medical Laser Technology, Inc. M.L.T. 30 CO2 Laser). The key argument for acceptance was that the new device's specifications and indications for use are the same as or very similar to those of the predicate device. Therefore, no new performance data or clinical studies were conducted or required for this 510(k) submission.

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The MLT R694 Ruby Laser System is intended to remove unwanted body hair. Patient selection criteria include patients with skin types 1-4.

The MLT R694 laser is a normal or long pulse ruby laser which emits a beam of coherent light at 694 nanometers.

The provided text states that no performance data was required for the MLT R694 Ruby Laser System. The basis for this is that "The specifications and indications for use of the MLT R694 ruby system laser are the same or very similar to those of the claimed predicate devices."

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. No information about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to specific performance criteria is provided, as these studies were deemed unnecessary due to substantial equivalence to predicate devices.

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