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FDA 510(k), K171488, PSLT for PASCAL Streamline
FDA 510(k), K171488, PSLT for PASCAL Streamline
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510(K) Number: K171488
Device Name: PSLT for PASCAL Streamline
Manufacturer: Topcon Medical Laser Systems, Inc.
Device Classification Name: Laser, Ophthalmic
Regulation Number: 886.4390
Classification Product Code: HQF
Date Received: 05/22/2017
Decision Date: 11/27/2017
Regulation Medical Specialty: Ophthalmic
Device Name: PSLT for PASCAL Streamline
Manufacturer: Topcon Medical Laser Systems, Inc.
Device Classification Name: Laser, Ophthalmic
Regulation Number: 886.4390
Classification Product Code: HQF
Date Received: 05/22/2017
Decision Date: 11/27/2017
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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