Nanolas Nd:Yag Ophthalmic Laser

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K881459 ↗

FDA Product Code

LOI

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Needle or Cutter

  Class II

  FDA 510(k) K953399 Active Cleared 30 Oct 1995

• Paxial

  Class II

  FDA 510(k) K853116 Active Cleared 31 Oct 1985

• Indirect Ophthalmoscope Accessory Delivery System

  Class II

  FDA 510(k) K890509 Active Cleared 24 Mar 1989

• Sterile Disposable Endocular Probe

  Class II

  FDA 510(k) K884456 Active Cleared 9 Dec 1988

• Ophthalas Dye Ophthalmic Laser

  Class II

  FDA 510(k) K873460 Active Cleared 29 Oct 1987

• Interconn. of Ophthalas & Nanolas Laser System

  Class II

  FDA 510(k) K883719 Active Cleared 18 Oct 1988

See all devices from Biophysic Medical, Inc. →

• What specific ophthalmic procedures is this Nd:YAG laser designed for, and what procedures does it exclude?

  This Nanolas Nd:YAG Ophthalmic Laser is designed for ophthalmic applications *excluding* posterior capsulotomy and pupillary cutting. It delivers focused laser energy for precise surgical interventions in eye care, such as treating conditions like iris synechiae, anterior hyaloid membrane removal, or other targeted procedures where controlled laser energy is required.

• Is this device single-use or reusable, and what maintenance or care is required to ensure proper function?

  The Nanolas Nd:YAG Ophthalmic Laser is a reusable medical instrument, intended for use in controlled clinical settings like ophthalmology clinics or operating rooms. Since it is reusable, it must be handled, stored, and maintained according to regulatory guidelines to ensure safety and efficacy. This includes regular cleaning, calibration, and adherence to manufacturer instructions to prevent contamination or performance degradation.

• How was this device’s regulatory clearance determined, and what classification does it fall under?

  The Nanolas Nd:YAG Ophthalmic Laser received FDA clearance under the traditional 510(k) review pathway, specifically classified as Substantially Equivalent (SESE) to a predicate device. It is categorized as a Class III laser under FDA regulations, which requires premarket approval for most devices in this category, though this particular clearance was granted via the 510(k) process. The product code assigned is LOI, indicating its ophthalmic use.

• What type of clinical settings is this laser intended for, and why?

  This device is designed for use in controlled clinical settings, such as ophthalmology clinics or operating rooms, due to its precision requirements and the need for sterile conditions. Nd:YAG lasers require trained personnel to operate safely, and the controlled environment ensures proper handling, maintenance, and adherence to protocols that minimize risks like tissue damage or unintended laser exposure.