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
HRCClass II

Sterilizer, Soft-Lens, Thermal, Battery-Powered

21 CFR 886.5928 / Ophthalmic
FDA source (opens on fda.gov)

HRC is the FDA product code for Sterilizer, Soft-Lens, Thermal, Battery-Powered, a class II device type, regulated under 21 CFR 886.5928. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HRC
Device name
Sterilizer, Soft-Lens, Thermal, Battery-Powered
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code HRC

By decision year
1 clearance under product code HRC with a decision year between 1992 and 1992, 1992 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HRC by decision year
YearClearances
19921

Applicants with the most clearances

Product code HRC
Applicants holding the most 510(k) clearances under product code HRC
ApplicantClearances
Osteo AG1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HRC.