Bioptron Ag

FDA Filings

This page includes the latest FDA filings for Bioptron Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003775404
• FEI Number: 3003775404
• Name: KEVIN - WALLS
• Owner & Operator: BIOPTRON AG
• Contact Address: SIHLEGGSTRASSE 23 --; WOLLERAU CH-NOTA CH-8832 CH
• US Agent:
  • KEVIN - WALLS
  • REGULATORY INSIGHT, INC.
  • 720 9625412
  • 720 9625413
  • kevin@reginsight.com
• Importing Logistics Registration:
  • Importer: Zepter International
  • Address: 8400 River Road ; North Bergen, NJ 07047 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 33 Golden Eagle Lane --; Littleton, CO 80127 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3013929417
• FEI Number: 3013929417
• Name: BIOPTRON AG
• Owner & Operator: BIOPTRON AG
• Contact Address: SIHLEGGSTRASSE 23 --; WOLLERAU CH-NOTA CH-8832 CH
• US Agent:
  • Kevin Walls
  • REGULATORY INSIGHT, INC.
  • 720 9625412 0
  • 720 9625413
  • KEVIN@REGINSIGHT.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Gouttes d Or 30 ; Neuchatel Neuchatel, 2008 CH
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K032216 | NHN KEVIN - WALLS [BIOPTRON AG]	BIOPTRON Pro (BPro) Light Therapy System	2007-10-08
PMN K032216 | NHN KEVIN - WALLS [BIOPTRON AG]	BIOPTRON PRO 1 (BPro1) Light Therapy System	2007-10-08
PMN K032216 | NHN KEVIN - WALLS [BIOPTRON AG]	BIOPTRON MedAll	2007-10-08
PMN K032216 | NHN KEVIN - WALLS [BIOPTRON AG]	BIOPTRON Compact III (BCIII) Light Therapy System	2007-10-08
PMN K032216 | NHN KEVIN - WALLS [BIOPTRON AG]	BIOPTRON 2 (B2) Light Therapy System	2007-10-08
PMN K032216 | NHN BIOPTRON AG	BIOPTRON Pro (BPro) Light Therapy System	2007-10-08
PMN K032216 | NHN BIOPTRON AG	BIOPTRON PRO 1 (BPro1) Light Therapy System	2007-10-08
PMN K032216 | NHN BIOPTRON AG	BIOPTRON MedAll	2007-10-08
PMN K032216 | NHN BIOPTRON AG	BIOPTRON Compact III (BCIII) Light Therapy System	2007-10-08
PMN K032216 | NHN BIOPTRON AG	BIOPTRON 2 (B2) Light Therapy System	2007-10-08
PMN K032216 BIOPTRON AG	BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM	2004-02-04