(126 days)
The Fraxel IV SR Laser System and accessories is intended for use in:
Dermatological procedures requiring the coagulation of soft tissue;
Treatment of periorbital wrinkles;
Treatment of acne scars and surgical scars;
Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;
Skin resurfacing procedures.
The Fraxel IV SR Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the skin.
The provided text for K063808 is a 510(k) summary of safety and effectiveness for a medical device (Fraxel IV SR Laser System and Accessories). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the new device meets specific, novel acceptance criteria through a dedicated study.
Therefore, the document does not contain the information requested for a detailed breakdown of acceptance criteria and a study proving the device meets them.
Here's why and what information is contained:
- No Acceptance Criteria or Device Performance Table: The document does not define specific performance metrics or acceptance criteria for the Fraxel IV SR Laser System. Instead, it relies on demonstrating that its indications for use and technological characteristics are substantially equivalent to already approved predicate devices.
- No Dedicated Study to Prove Criteria: Because no new, specific acceptance criteria are presented for this device, there is no study described that aims to prove the device meets such criteria. The "Clinical Performance Data" section merely states, "Sufficient safety data has been gathered to determine that the Fraxel IV Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced." This is a general statement, not a detailed study report.
- No Information on Sample Sizes, Data Provenance, Expert Ground Truth, or Adjudication: Since there isn't a detailed study described for this device, there is no information about sample sizes for test sets, data provenance, the number or qualifications of experts, or adjudication methods.
- No MRMC or Standalone Study Information: The document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies. The Fraxel IV SR is a physical laser system, not an AI or imaging diagnostic tool.
- No Ground Truth Type or Training Set Information: As there's no diagnostic or analytical algorithm being evaluated, the concepts of ground truth (expert consensus, pathology, outcomes data) and training sets are not applicable or discussed in this context.
In summary, the provided 510(k) pertains to demonstrating substantial equivalence, not to presenting a study proving a device meets specific quantitative acceptance criteria.
§ 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.