(122 days)
The Peterio Universal Laser Scanning Handpiece is intended to be used as an accessory to a compatible non-ablative 1064nm laser and for its legally marketed, dermatological indications including: Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin; Coagulation and hemostasis of sub-surface vascular lesions.
The Peterio™ Universal Laser Scanning Handpiece is an accessory for a legally marketed, compatible laser system. It is hand held device which attaches to the distal end of the laser system and delivers rapid scanning of the laser beam over a predetermined surface area. The Peterio has been designed for delivering the energy fluence equivalent to that of legally marketed compatible lasers, to a confined volume at a selectable tissue depth, while at the same time the Peterio exposes the tissue surface to less than 10% of the fluence of such lasers.
The provided 510(k) summary for the Peterio™ Universal Laser Scanning Handpiece (K073048) does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The 510(k) summary focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It describes the device, its intended use, and compares it to predicate devices, stating that it "is substantially equivalent to its predicate devices in that it is an accessory to a legally marketed laser system and scans the laser beam with rotating mirrors." It also mentions "same basic intended use."
The document does not include:
- A table of acceptance criteria or reported device performance.
- Details on sample sizes for test sets or data provenance.
- Information on ground truth establishment (number/qualifications of experts, adjudication methods).
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance data.
- Details on the type of ground truth used (e.g., pathology, outcomes data).
- Information regarding the training set size or how its ground truth was established.
This is typical for a 510(k) submission where substantial equivalence is primarily based on comparison to existing legally marketed devices, rather than a de novo demonstration of safety and effectiveness through extensive clinical trials with specific performance metrics. The focus is on demonstrating that the new device does not raise new questions of safety and effectiveness compared to its predicates.
§ 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.