(190 days)
The LightSheer™ is intended to effect temporary hair reduction in skin types I-IV. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
The LightSheer™ operates at a wavelength of 694.3 nanometers and the beam has a pulse duration of 3 and 20 milliseconds. Energy fluences of 10-60 J/cm² are achieved under conditions of intended use. A thermoelectrically cooled handpiece is held firmly against the treatment site.
The provided document is a 510(k) summary for the LightSheer™ Long Pulse Ruby Laser. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a traditional clinical trial report would.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set) are not applicable or not provided by this type of regulatory submission.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a study designed to prove the device meets those criteria. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices for the specified indications for use.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| (Not explicitly stated as quantitative acceptance criteria) | "effective for producing a stable long-term, permanent reduction of hair." (Conclusion statement) | The device is deemed "effective" for its intended use, based on its characteristics being substantially equivalent to predicates that have established effectiveness. No specific %> reduction or success rate is provided as an acceptance criterion or performance measure. |
| Intended Use: |
- Temporary hair reduction in skin types I-IV
- Stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanin in hair follicles. (Permanent hair reduction defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.) | The 510(k) cleared the device for these specific Indications for Use. | Clearance implies the FDA found sufficient evidence (through substantial equivalence) that the device can achieve these intended effects. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Not provided. The document states "Clinical Data: None required," indicating that a separate clinical efficacy study with a test set was not submitted for this 510(k) clearance. Clearance was based on substantial equivalence to predicate devices and engineering/performance data (though not detailed here).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. As no clinical efficacy study with a test set was required/submitted, there was no need for experts to establish ground truth for such a set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical efficacy study with a test set.
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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 for hair reduction, not an AI-assisted diagnostic imaging device that would typically involve human "readers" or an MRMC study.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (laser system), not an algorithm or AI. Its performance is inherent to its physical operation, not an automated interpretation without human involvement. Humans operate the device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated as generated for this submission. The regulatory decision is based on a determination of substantial equivalence to predicate devices which presumably had their effectiveness established historically, potentially through clinical outcomes data or other means suitable for their time of clearance. For this specific 510(k), no new "ground truth" for a performance study was generated.
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The sample size for the training set:
- Not applicable. This device is hardware (laser system), not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
Summary of Regulatory Approach:
This 510(k) submission for the LightSheer™ Long Pulse Ruby Laser gained market clearance through the "substantial equivalence" pathway. This means the manufacturer demonstrated that their device is as safe and effective as a legally marketed predicate device (in this case, other LightSheer™ models and the EpiLaser® Normal Mode Ruby Laser). This pathway often does not require new clinical efficacy studies if the technological characteristics and indications for use are sufficiently similar to the predicate. The statement "Clinical Data: None required" confirms this approach for this particular submission.
§ 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.