Laser Centering Device

FDA 510(k) K872747 · Innomed Corp.

Substantially Equivalent

510(k) numberK872747

Submission

Device name
Laser Centering Device
Applicant
Innomed Corp.
Brea, CA, US
Received
July 13, 1987
Decision date
September 4, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HMR – Marker, Ocular
Device class
Class I (low risk)
Regulation
21 CFR 886.4570
Specialty
Ophthalmic

Other 510(k)s with product code HMR

510(k)DeviceApplicantDecision
K053475Optipoint Corneal Marker, Model VPT-OPT-450HMR · Traditional Refractec, Inc.03/03/2006SE
K925606Optical Zone/Hexagonal/Astigmatism/Radial MarkersHMR · Traditional Chiron Vision Corp.08/29/1994SE
K863663Ophthalmic Surgical Ocular MarkersHMR · Traditional Myocure, Inc.10/20/1986SE
K861535Optical Markers/Fixation Ring/Cannu & Irriga CannuHMR · Traditional CooperVision, Inc.05/14/1986SE

More from CooperVision, Inc.

510(k)DeviceDecision
K822574Innomed PD-1 KitLJL · Traditional 10/13/1982SE
K827796Innoscan Examination Light · Traditional 08/24/1982SE

Questions and answers

When was Laser Centering Device cleared by the FDA?

Laser Centering Device (K872747) received a 510(k) decision of Substantially Equivalent on September 4, 1987, 53 days after the submission was received.

What is the product code of K872747?

The FDA product code is HMR – Marker, Ocular, a Class I (low risk) device regulated under 21 CFR 886.4570.