HQS — Burr, Corneal, Ac-Powered Class I

FDA Device Classification

FDA product code HQS covers "Burr, Corneal, Ac-Powered", a Class I medical device regulated under 21 CFR 886.4070. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
HQS
Device Class
Class I
Regulation Number
886.4070
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K971078medjetHYDROBRUSH (TM) KERATOMEJanuary 23, 1998