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VISULAS 690S LASER AND VISULINK PDT ADAPTER

FDA premarket approval P990048/S002 · decided 2001-07-03

Approval details

PMA number
P990048
Supplement
S002
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
VISULAS 690S LASER AND VISULINK PDT ADAPTER
Generic name
System, laser, photodynamic therapy
Applicant
Carl Zeiss Meditec, AG
Date received
2001-03-09
Decision date
2001-07-03
Days to decision
116 days
Decision code
APPR
Product code
MVF
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Dublin, CA
Statement
APPROVAL FOR MODIFICATIONS TO THE VISULINK PDT ADAPTER IN ORDER TO MAKE THE VISULAS 790S LASER COMPATIBLE WITH BOTH ZEISS AND HAAG STREIT SLIT LAMPS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE WITH THE VISULAS 690S LASER THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE(VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION (AMD) IN PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZAT

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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