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The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.

The Cell Robotics Ultra-Light Laser System is an Er: Y AG laser producing emission at a wavelength of 2940nm. The laser consists of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the handpiece, which houses the laser.

This 510(k) summary for the Cell Robotics Ultra-Light Laser System states "Nonclinical Performance Data: None Required" and "Clinical Performance Data: None Required". Therefore, a study proving the device meets acceptance criteria was not part of this submission, nor were acceptance criteria explicitly defined in terms of device performance metrics.

The FDA's decision to clear the device was based on a finding of substantial equivalence to legally marketed predicate devices, rather than on new performance data demonstrating its adherence to specific acceptance criteria.

Therefore, most of the information requested in your prompt cannot be provided from the given document, as no performance study was conducted or submitted:

Here's what can be inferred or explicitly stated based on the provided text:

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

• Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criterion for this 510(k) submission was "substantial equivalence" to predicate devices.
• Reported Device Performance: No specific performance data (e.g., accuracy, precision) was reported or required for this 510(k) submission.

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

• Not applicable, as no performance study was conducted.

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 applicable, as no performance study was conducted.

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

• Not applicable, as no performance study was conducted.

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 diagnostic tool, and no clinical performance studies were required or submitted.

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

• Not applicable. This device is a laser system.

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

• Not applicable, as no performance study was conducted.

8. The sample size for the training set:

• Not applicable, as no performance study was conducted.

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

• Not applicable, as no performance study was conducted.

Summary from the document:

The Cell Robotics Ultra-Light Laser System was cleared based on its substantial equivalence to three legally marketed predicate devices:

• Schwartz Electro-Optics TriLase2940, K# 954013
• Cell Robotics Er: YAG Laser System, K# 970461
• Asceplion-Meditec Dermastar Er: YAG Laser System, K#014057

The FDA determined that "Nonclinical Performance Data: None Required" and "Clinical Performance Data: None Required" for this submission, indicating that the device's technological characteristics and intended use were sufficiently similar to the predicates that new performance studies were not deemed necessary to establish safety and effectiveness.

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