Home / Import refusals / 9VT-0036039-3/11/1

FDA Import Refusal 9VT-0036039-3/11/1 — Cynosure, LLC

Cynosure, LLC — FEI 1000120578

The FDA refused shipment 9VT-0036039-3/11/1 from Cynosure, LLC (United States) on December 2, 2022. The refused product falls under Devices — POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT. Cited charges: 118,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 2, 2022
Country
United States
Product Category
Devices
Product Code
79ONG POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT
Charges
118,3280

Recent inspections

  • 1295506 (NAI Fri Dec 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060207 (NAI Fri Jul 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003091 (NAI Mon Mar 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904967 (VAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876385 (VAI Mon Apr 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-1379267-9/10001/1 (Tue Sep 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-5743480-8/11/1 (Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 9VT-0028133-4/11/1 (Mon Aug 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-1621920-7/11/1 (Tue Oct 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • CDJ-0002485-9/11/1 (Wed Jun 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources