Lds - Laser Delivery System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862568 ↗

FDA Product Code

HQF

Device Class

Class II

Regulation

21 CFR Part 886.4390

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Coherent Xa-30 CO2 Surgical Laser

  Class II

  FDA 510(k) K873963 Active Cleared 19 Oct 1987

• Model 5001 Micromanipulator for Use W/Tf-25 CO2

  Class II

  FDA 510(k) K873246 Active Cleared 10 Nov 1987

• Versapulse(Tm) Twopointone/Xe Holmium Surg Lasers

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  FDA 510(k) K914991 Active Cleared 6 May 1992

• Laser Indirect Ophthalmoscope (Lio)

  Class II

  FDA 510(k) K885196 Active Cleared 11 Jan 1989

• Model 920 Argon/Dye Laser-for Dermatological/Use

  Class II

  FDA 510(k) K852860 Active Cleared 7 Oct 1985

• Acculite(Tm) Otoprobe

  Class II

  FDA 510(k) K930981 Active Cleared 28 Jul 1993

See all devices from Coherent Medical Group →

• What is the LDS-20 Laser Delivery System used for?

  The LDS-20 is designed specifically for ophthalmic argon laser photocoagulation procedures. It targets retinal and anterior segment conditions by delivering focused laser energy through a slit lamp biomicroscope, enabling precise treatment of targeted ocular tissues.

• How is the LDS-20 Laser Delivery System supplied and where is it used?

  The LDS-20 is a reusable, non-sterile device intended exclusively for clinical ophthalmology settings. It is mounted on a motorized ophthalmic table with an integrated power supply base, ensuring stability and ease of use during procedures.

• Does the LDS-20 require sterilization between uses?

  No, the LDS-20 is classified as a non-sterile device. However, it must undergo proper maintenance and calibration as outlined by the manufacturer to ensure optimal performance and safety between uses.

• What maintenance or calibration is required for the LDS-20?

  Since the LDS-20 is a reusable Class II medical device, it requires regular maintenance and calibration to comply with manufacturer guidelines. This ensures consistent laser delivery accuracy and device reliability for clinical procedures.

• Is the LDS-20 approved for specific regulatory pathways?

  Yes, the LDS-20 holds an FDA 510(k) clearance (K862568) under the Traditional pathway, classified as substantially equivalent for ophthalmic applications. It is also listed under the product code HQF and regulation number 886.4390.