Topcon Medical Laser Systems, Inc.
Topcon Medical Laser Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2018, with 2 FDA device recalls on record.
Top product codes for Topcon Medical Laser Systems, Inc.
FDA recalls by Topcon Medical Laser Systems, Inc.
- Z-2405-2016 — Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
- Z-1774-2013 — PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Topcon Medical Laser Systems, Inc.
- K180402 — PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
- K171488 — PSLT for PASCAL Streamline
- K123542 — PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
- K111108 — PASCAL STREAMLINE 577 (WITH ACCESSORIES)
- K092621 — PASCAL STREAMLINE PHOTOCOAGULATOR
- K043486 — PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
Data sourced from openFDA. This site is unofficial and independent of the FDA.