(139 days)
The Light Age Q-Clear™ Laser is indicated for the following uses:
- For incision, excision, ablation, and vaporization of soft tissue for General Dermatology
- The 1064nm wavelength is indicated for:
- Dark ink tattoo removal
- Removal of pigmented lesions (particularly Nevus of Ota)
- Removal or lightening of hair
- Skin resurfacing with or without adjuvant preparation
- Treatment of common nevi
- The 532nm wavelength is indicated for:
- Removal of light ink (red, tan, purple and orange) tattoos
- Treatment of common nevi
- Treatment of café-au-lait spots
- Treatment of seborrheic keratoses
- Treatment of vascular lesions, including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains, and most pigmented lesions (e.g. lentigines, and ephelides)
The Light Age Q-Clear™ Laser has a Nd: Y AG crystal rod as a lasing medium. Pulsed energy is emitted at 1064 nanometers in the near-infrared portion of the spectrum. With the optional frequency doubler installed, a 532nm beam is emitted. The laser is delivered directly to the target area via the handpiece, which produces a circular beam on the skin. A red aiming beam is provided to allow the operator to precisely target the treatment area. The Q-Clear™ Laser is equipped with safety features in conformance with 21CFR Part 1040.
The provided text is a 510(k) summary for the Light Age Q-Clear™ Laser. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document is a regulatory submission for premarket notification, asserting that the device is "substantially equivalent" to previously cleared devices. This type of submission often relies on demonstrating that the new device has the same technological characteristics and intended use as predicate devices, and does not raise new questions of safety or efficacy. It generally does not include detailed performance studies with acceptance criteria in the way a clinical trial or a specific analytical performance study for a diagnostic device would.
Therefore, I cannot provide the requested information from the provided text.
Specifically, the following information is not available in the provided document:
- A table of acceptance criteria and the reported device performance: This document asserts substantial equivalence, not specific performance metrics against defined acceptance criteria.
- Sample size used for the test set and the data provenance: No performance study is described that would have a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for a test set is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a laser device, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document's statement regarding safety and effectiveness is: "The Light Age Q-Clear™ Laser has the same wavelengths, the same spot size, the same Frie Light of operation, essentially the same fluence levels, and the same intended use as the predicate devices. The Light Age Q-Clear™ Laser does not raise new questions of safety or efficacy, and is substantially equivalent to the predicate devices." This is the core argument for its approval, not a report of meeting specific performance criteria from a new study.
§ 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.