LIPIFLOW THERMAL PULSATION SYSTEM


Device Classification Name

eyelid thermal pulsation system

510(k) Number K112704
Device Name LIPIFLOW THERMAL PULSATION SYSTEM
Applicant
TEARSCIENCE, INC.
5151 mccrimmon parkway
suite 250
morrisville, 
NC 
27560

Applicant Contact christy stevens
Correspondent
TEARSCIENCE, INC.
5151 mccrimmon parkway
suite 250
morrisville, 
NC 
27560

Correspodent Contact christy stevens
Regulation Number 886.5200
Classification Product Code
ORZ  
Date Received 09/16/2011
Decision Date 12/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No