HLWClass II

Preamplifier, Battery-Powered, Ophthalmic

21 CFR 886.1640 / Ophthalmic

HLW is the FDA product code for Preamplifier, Battery-Powered, Ophthalmic, a class II device type, regulated under 21 CFR 886.1640. As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 1990-02-09, and no recalls.

Classification record

Product code: HLW
Device name: Preamplifier, Battery-Powered, Ophthalmic
Regulation: 21 CFR 886.1640
Device class: Class II
Review panel: Ophthalmic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 3
Ingested recalls: 0

Clearances, product code HLW

By decision year

3 clearances under product code HLW with a decision year between 1986 and 1990, 1990 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code HLW by decision year
Year	Clearances
1986	1
1990	2

Applicants with the most clearances

Product code HLW

Applicants holding the most 510(k) clearances under product code HLW
Applicant	Clearances
Oculinum, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HLW.

Recent clearances

Product code HLW

Recent recalls

Product code HLW

FDA records show no recalls under product code HLW.

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)