(143 days)
The iFS Laser System is an ophthalmic surgical laser indicated for use:
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments
- In lamellar keratoplasty and corneal harvesting
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
The iFS Laser System is a precision ophthalmic surgical laser designed for use as an ophthalmic surgical laser indicated for use:
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea:
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments;
- In lamellar keratoplasty and corneal harvesting;
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the . creation of a penetrating cut/incision for penetrating keratoplasty.
Corneal dissection with the iFS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.
The provided text describes a 510(k) summary for the iFS Laser System, an ophthalmic surgical laser. While it details the device, its intended use, and claims substantial equivalence to predicate devices, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria, study details, and performance metrics.
The document primarily focuses on establishing regulatory equivalence and does not elaborate on clinical studies, performance metrics, ground truth establishment, or sample sizes beyond stating that the device "perform[s] equivalently to the predicate laser and patient interface for the creation of corneal resections."
Therefore, I cannot provide the requested information from the given text.
In a real-world scenario, such information would typically be found in detailed clinical study reports, performance testing reports, or more extensive sections of a 510(k) submission that are not included in this summary.
§ 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.