VISULAS ND:YAG LASER

Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Premarket Approval P850083 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceVISULAS ND:YAG LASER
Classification NameLaser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
Generic NameLaser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
ApplicantCARL ZEISS, INC.
Date Received1986-08-15
Decision Date1987-03-10
PMAP850083
SupplementS001
Product CodeLOI
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CARL ZEISS, INC. one Zeiss Dr. thornwood, NY 10594

Supplemental Filings

Supplement NumberDateSupplement Type
P850083Original Filing
S008 1988-09-21 Normal 180 Day Track
S007 1988-01-15 Normal 180 Day Track
S006 1987-09-14 Normal 180 Day Track
S005 1987-08-12 Normal 180 Day Track
S004 1986-11-14 Normal 180 Day Track
S003 1986-10-08 Normal 180 Day Track
S002
S001 1986-08-15 Normal 180 Day Track

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