510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904248Substantially Equivalent

Model Glase 210 Holmium Laser System

Charles L. Rose and Co., Inc., Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904248 is the FDA 510(k) clearance record for MODEL GLASE 210 HOLMIUM LASER SYSTEM, a class II device, cleared for Charles L. Rose and Co., Inc. on under FDA product code HGF (Source, Abortion Unit, Vacuum). FDA records list 4 510(k) clearances for Charles L. Rose and Co., Inc., from to . As of , FDA records show no recalls naming K904248.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HGF Source, Abortion Unit, Vacuum
Regulation
21 CFR 884.5070
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Charles L. Rose and Co., Inc. 1963 Rock St., Mountain View CA
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