510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852464Substantially Equivalent

Hcg, Inc. Medical Laser Endocoagulator Model P.c.

Hcg, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852464 is the FDA 510(k) clearance record for HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C., a class II device, cleared for Hcg, Inc. on under FDA product code HQF (Laser, Ophthalmic). FDA records list one 510(k) clearance for Hcg, Inc. As of , FDA records show no recalls naming K852464.

Clearance record

Decision date
Received
(45 days to decision)
Product code
HQF Laser, Ophthalmic
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Hcg, Inc. 1828 S. 3850 W., Salt Lake City UT
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