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
K890787Substantially Equivalent

O-020 Laser Indirect Ophthalmoscope

Hgm Medical Laser Systems, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890787 is the FDA 510(k) clearance record for O-020 LASER INDIRECT OPHTHALMOSCOPE, a class II device, cleared for Hgm Medical Laser Systems, Inc. on under FDA product code HGF (Source, Abortion Unit, Vacuum). FDA records list 18 510(k) clearances for Hgm Medical Laser Systems, Inc., from to . As of , FDA records show no recalls naming K890787.

Clearance record

Decision date
Received
(37 days to decision)
Product code
HGF Source, Abortion Unit, Vacuum
Regulation
21 CFR 884.5070
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hgm Medical Laser Systems, Inc. 3959 W. 1820 S., Salt Lake City UT
Third party review
No

Clearances, product code HGF

Trailing 12 months

FDA records hold no clearances under product code HGF in the trailing twelve months.

FDA records show no clearances under product code HGF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HGF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260