510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OTLClass III

Femtosecond Laser System For Refractive Correction

Unknown
FDA source (opens on fda.gov)

OTL is the FDA product code for Femtosecond Laser System For Refractive Correction, a class III device type. FDA's definition for this code reads: "Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OTL
Device name
Femtosecond Laser System For Refractive Correction
FDA definition
Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code