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VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER

FDA premarket approval P990048/S003 · decided 2008-10-31

Approval details

PMA number
P990048
Supplement
S003
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER
Generic name
System, laser, photodynamic therapy
Applicant
Carl Zeiss Meditec, AG
Date received
2008-04-22
Decision date
2008-10-31
Days to decision
192 days
Decision code
APPR
Product code
MVF
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Dublin, CA
Statement
APPROVAL FOR CHANGES TO THE LASER CONTROLLER; THE ADDITION OF NEW USER INTERFACE INCLUDING TOUCH-SENSITIEVE SCREEN AND ROTARY KNOBS; A NEW INTEGRATED POWER SUPPLY WITH MICRO-CONTROLLER ELECTRONIC COMPONENTS; NEW LABELING; AND NEW SOFTWARE (FIRMWARE). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULAS 690PLUS AND VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE IN VISUDYNE THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE (VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF PATIENT

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510(k) clearances by this applicant

RecordFirmDate
ZEISS CLINIC 360 (K260694)Carl Zeiss Meditec, AG2026-07-17
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (K241174)Carl Zeiss Meditec, AG2025-01-10
VISULAS combi (K233911)Carl Zeiss Meditec, AG2024-09-06
BLUE 400; BLUE 400 S (K240215)Carl Zeiss Meditec, AG2024-06-28
RESCAN 700 (K233421)Carl Zeiss Meditec, AG2024-03-08
CALLISTO eye (K232944)Carl Zeiss Meditec, AG2023-12-21
QEVO System (K232159)Carl Zeiss Meditec, AG2023-09-21
CALLISTO eye (K231676)Carl Zeiss Meditec, AG2023-08-28