Home / Import refusals / 9TV-0000378-0/1/1

FDA Import Refusal 9TV-0000378-0/1/1 — Solta Medical Inc

Solta Medical Inc — FEI 3003079710

The FDA refused shipment 9TV-0000378-0/1/1 from Solta Medical Inc (United States) on February 25, 2015. The refused product falls under Devices — POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT. Cited charge: 341 This firm has 4 other import refusals on record.

Refusal Details

Date
February 25, 2015
Country
United States
Product Category
Devices
Product Code
79ONG POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT
Charges
341

Recent inspections

  • 882308 (VAI Tue Jun 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873862 (NAI Thu Apr 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798415 (OAI Fri Aug 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 755598 (NAI Fri Dec 02 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • ES3-2528351-4/51/1 (Fri Aug 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-2310202-0/1/1 (Fri Aug 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • DO7-7810269-2/1/1 (Fri Nov 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • ANQ-2030199-0/1/1 (Tue Aug 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources