HOOClass I

Perimeter, Ac-Powered

21 CFR 886.1605 / Ophthalmic

HOO is the FDA product code for Perimeter, Ac-Powered, a class I device type, regulated under 21 CFR 886.1605. As of 2026-09-10, FDA records hold 6 510(k) clearances under this code, the most recent dated 1994-06-06, and no recalls.

Classification record

Product code: HOO
Device name: Perimeter, Ac-Powered
Regulation: 21 CFR 886.1605
Device class: Class I
Review panel: Ophthalmic
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 6
Ingested recalls: 0

Clearances, product code HOO

By decision year

6 clearances under product code HOO with a decision year between 1983 and 1994, 1986 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HOO by decision year
Year	Clearances
1983	1
1986	2
1987	1
1993	1
1994	1

Applicants with the most clearances

Product code HOO

Applicants holding the most 510(k) clearances under product code HOO
Applicant	Clearances
Bio-Rad	1
CooperVision, Inc.	1
Keeler Instruments, Inc.	1
Marco Ophthalmic, Inc.	1
Richmond Products, Inc.	1
Welch Allyn Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code HOO

Recent recalls

Product code HOO

FDA records show no recalls under product code HOO.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)