MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER


Device Classification Name

lenses, soft contact, daily wear

510(k) Number K030167
Device Name MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
Original Applicant
CLEARLAB PTE LTD.
2214 sanford drive, b7
grand junction, 
CO 
81505

Original Contact martin dalsing
Regulation Number 886.5925
Classification Product Code
LPL  
Date Received 01/16/2003
Decision Date 04/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No