LASER IRAS— 510(k) K853556

Substantially Equivalent

Randwal Instrument Co., Inc.

FDA 510(k) clearance K853556 for LASER IRAS, Substantially Equivalent on 1985-11-01. Applicant: Randwal Instrument Co., Inc.. Device class: 2.

Clearance details

Applicant: Randwal Instrument Co., Inc.
Product code: Code HPJ
Device class: Class 2
Regulation: 21 CFR 886.1360
Advisory panel: Ophthalmic
Date received: 1985-08-26
Decision date: 1985-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southbridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HPJ

K864012 — IRAS PERIMETER1986-12-12
K822415 — THE OCUPLOT D1982-09-07
K813429 — LASER PHOTOCOAGULATOR ARGON MED. LASER1982-01-22
K781507 — RETINOMETER1978-11-15

More clearances from Randwal Instrument Co., Inc.

K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR1988-02-05
K873987 — IRAS GLARE TESTER1987-11-24
K842567 — PORTABLE ACUIOMETER1984-08-15
K827577 — VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER1983-01-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.