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

Laser, Surgical, Gynecologic

21 CFR 884.4550 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HHR is the FDA product code for Laser, Surgical, Gynecologic, a class II device type, regulated under 21 CFR 884.4550. As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HHR
Device name
Laser, Surgical, Gynecologic
Regulation
21 CFR 884.4550
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
48
Ingested recalls
0

Clearances, product code HHR

By decision year
48 clearances under product code HHR with a decision year between 1977 and 1989, 1986 the highest year at 14.
Show the numbers
510(k) clearances under FDA product code HHR by decision year
YearClearances
19772
19791
19802
19811
19821
19856
198614
19878
198812
19891

Applicants with the most clearances

Product code HHR
Applicants holding the most 510(k) clearances under product code HHR
ApplicantClearances
Cooper Lasersonics, Inc.4
Directed Energy, Inc.4
Endo Lase, Inc.3
Laser Media2
Laserscope2
Merrimack Laboratories2
Minnesota Laser Corp.2
Photon Sources2
Surgical Laser Technologies, Inc.2
Advanced Biomedical Instruments1

Companies listing this code with FDA

Companies whose registered establishments list this code