PHOTOTOME(TM) SYSTEM 2700

FDA Premarket Approval P850019 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

DevicePHOTOTOME(TM) SYSTEM 2700
Generic NameLaser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
ApplicantLASER MEDIA
Date Received1985-10-28
Decision Date1985-12-24
PMAP850019
SupplementS001
Product CodeLOI 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address LASER MEDIA 77 Arkay Dr. hauppauge, NY 11788

Supplemental Filings

Supplement NumberDateSupplement Type
P850019Original Filing
S002 1986-09-08 Normal 180 Day Track
S001 1985-10-28

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