510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K050541Substantially Equivalent

Omniguide Beampath CO2 Mark I Laser Beam Delivery

Omniguide Communications, Inc., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050541 is the FDA 510(k) clearance record for OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY, a class II device, cleared for Omniguide Communications, Inc. on under FDA product code HQF (Laser, Ophthalmic). FDA records list one 510(k) clearance for Omniguide Communications, Inc. As of , FDA records show no recalls naming K050541.

Clearance record

Decision date
Received
(68 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Omniguide Communications, Inc. One Kendall Sq., Bldg. 100, Cambridge MA
510(k) summary
Summary PDF
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