(90 days)
The UltraPulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: dermatology and plastic surgery (aesthetic), podiatry , gynecology, general and oral surgery, dental and oral surgery and genitourinary surgery as follows:
The UltraPulse SurgiTouch and UltraPulse Encore CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:
The Lumenis Be Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (subject devices) consist of the following devices:
Laser Systems
- o UltraPulse Alpha (also written as UltraPulse α)
- UltraPulse Encore o
- UltraPulse SurgiTouch o
Delivery Devices and Accessories
- o DeepFX Microscanner and disposable tips
- UltraScan CPG Microscanner o
- o TrueSpot 2.0 mm Collimated Handpiece
- o 0.2 mm and 1.0 mm Focused Incisional Handpieces (also called Standard Handpieces)
Each UltraPulse laser system is an advanced computer-controlled device with RF - modulated CO2 laser tube technology that emits laser beams at a wavelength of 10,600 or 11,100 nm. Each has an additional diode laser in the red visible spectrum emitting along the same optical path as the CO2 to serve as an aiming beam.
Attached to each laser system are the delivery devices and accessories that direct the laser beams to the intended treatment site in the format as selected by the user.
This document is a 510(k) premarket notification decision letter from the FDA regarding a CO2 Laser System for surgical and aesthetic applications. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
The document states:
- "For the labeling changes described in the 510(k), no testing was required." (Page 12)
- The entire submission is focused on "labeling changes" and a new manufacturer name, not performance evaluation of a new or modified device functionality that would require clinical or technical studies demonstrating performance metrics.
- The device being cleared is a traditional medical laser system, not an AI or algorithm-based device. Therefore, the concepts of "ground truth," "expert consensus," "training set," "test set," "MRMC study," and "human readers improve with AI assistance" are not applicable to this document.
Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert information, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) from the provided text. The document pertains to a regulatory clearance based on substantial equivalence for a non-AI device with labeling changes, not a performance study for an AI-enabled device.
§ 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.