510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864063Substantially Equivalent

Orion 3001, Laser Photocoagulator

G. Rodenstock Instrumente GmbH, Munchen 70, West Germany, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864063 is the FDA 510(k) clearance record for ORION 3001, LASER PHOTOCOAGULATOR, a class II device, cleared for G. Rodenstock Instrumente GmbH on under FDA product code HQF (Laser, Ophthalmic). FDA records list 3 510(k) clearances for G. Rodenstock Instrumente GmbH, from to . As of , FDA records show no recalls naming K864063.

Clearance record

Decision date
Received
(24 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
G. Rodenstock Instrumente GmbH Drachenseestrabe 10-12, Munchen 70, West Germany, DE
Third party review
No

Clearances, product code HQF

Trailing 12 months
2 clearances under product code HQF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260