HQL — Intraocular Lens Class III

FDA Device Classification

FDA product code HQL covers "Intraocular Lens", a Class III medical device regulated under 21 CFR 886.3600. Submissions are reviewed by the Ophthalmic panel. Devices under this code are implants. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HQL
Device Class
Class III
Regulation Number
886.3600
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K914311chiron ophthalmicsCHIROFLEX II LENS MICROSERT(TM)January 27, 1992
K913626staar surgicalSOFTRANS INJECTORDecember 18, 1991
K842892nidekNIDEK DIGITAL KERATOMETEROctober 5, 1984
K842504american medical opticsAMER. MEDICAL OPTICS DIGITAL KERATO-October 1, 1984
K771933california intraocular lensCILCO ANTERIOR CHAMBER LENSJanuary 26, 1978