Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of TopconLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Topcon Medical Laser Systems, Inc. with 8 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated May 25, 2018: PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 25, 2018 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStarK180402 · HQF | 510(k) clearances |
| Nov 27, 2017 | PSLT for PASCAL StreamlineK171488 · HQF | 510(k) clearances |
| Sep 12, 2017 | PASCAL Synthesis Twinstar Ophthalmic Scanning Laser SystemK170409 · GEX | 510(k) clearances |
| Jul 15, 2016 | Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conClass II · Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may oc | Device recalls |
| May 15, 2013 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASERK123542 · HQF | 510(k) clearances |
| Nov 13, 2012 | PASCAL LASER INDIRECT OPHTHALMOSCOPEK123056 · HQF | 510(k) clearances |
| Mar 27, 2012 | PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.Class II · When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and th | Device recalls |
| Aug 11, 2011 | PASCAL STREAMLINE 577 (WITH ACCESSORIES)K111108 · HQF | 510(k) clearances |
| Sep 25, 2009 | PASCAL STREAMLINE PHOTOCOAGULATORK092621 · HQF | 510(k) clearances |
| Mar 3, 2005 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01K043486 · GEX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
