SLT Contact Laser System Endophotocoagulation

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K882441 ↗

FDA Product Code

HQB

Device Class

Class II

Regulation

21 CFR Part 886.4690

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K890321 Active Cleared 5 Apr 1989

See all devices from Surgical Laser Technologies, Inc. →

• What is the SLT Contact Laser System Endophotocoagulation primarily used for in clinical practice?

  The SLT Contact Laser System Endophotocoagulation is designed specifically for selective laser trabeculoplasty (SLT) and endophotocoagulation procedures. It delivers controlled laser energy to the trabecular meshwork in the eye, aiming to improve aqueous humor outflow and help reduce intraocular pressure, which is particularly relevant for managing glaucoma. It is intended for ophthalmic use under direct visualization through a contact lens applicator.

• Is the SLT Contact Laser System Endophotocoagulation a single-use or reusable device?

  The SLT Contact Laser System Endophotocoagulation is supplied as a reusable medical instrument. There is no indication in the regulatory data that it is intended for single-use, so it is meant to be used repeatedly in clinical settings with appropriate maintenance and sterilization procedures.

• What regulatory pathway was followed for the FDA clearance of this device?

  The SLT Contact Laser System Endophotocoagulation received FDA clearance through a 510(k) submission, specifically under the Ophthalmic Advisory Committee (OP). The device was classified as a Class II medical device (21 CFR 886.4690) and was determined to be substantially equivalent to a predicate device. The submission was reviewed under the HQB product code and received clearance on September 26, 1988.

• How is the SLT Contact Laser System Endophotocoagulation intended to be used in a clinical setting?

  The device is intended for use in clinical settings by trained ophthalmologists. It requires direct visualization through a contact lens applicator during procedures, and while it is reusable, sterile procedures must be adhered to where applicable. The system is not intended for self-administration or use outside of professional medical environments.