COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT


Device Classification Name

lens, contact (other material) – daily

510(k) Number K024164
Device Name COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT
Original Applicant
METRO OPTICS, INC.
623 glacier dr.
grand junction, 
CO 
81503

Original Contact deanna werber
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 12/17/2002
Decision Date 02/12/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No