LPULSA SYL-9000 OPHTHALMIC YAG LASER

• K Number: K990075
• Device Name: LPULSA SYL-9000 OPHTHALMIC YAG LASER
• Manufacturer: LIGHT-MED (USA), INC.
• Date Cleared: 1999-03-30 ( 78 days)
• Product Code: HQF
• Regulation Number: 886.4390
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

Posterior Capsulotomy Pupillary Membranectomy

Device Description

LPULSA SYL-9000 Ophthalmic YAG Laser

AI/ML Overview

I apologize, but this document is a 510(k) clearance letter from the FDA for a medical device called the "LPULSA SYL-9000 Ophthalmic YAG Laser." This type of document confirms that the device is "substantially equivalent" to a legally marketed predicate device and can therefore be marketed.

While it specifies the "Indications for Use" (Posterior Capsulotomy and Pupillary Membranectomy), it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to the efficacy or performance studies that typically involve the questions you've asked. Such details are usually found in the 510(k) submission itself or in separate clinical study reports, which are not part of this clearance letter.

Therefore, I cannot provide the information you requested based on the provided document.

Regulation Number and Section

§ 886.4390 Ophthalmic laser.

(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.