Atlas FDA

NMR-K FUNDUS LASER LENS

FDA 510(k) clearance K910231 · decided 1991-01-28

Clearance details

K-number
K910231
Device name
NMR-K FUNDUS LASER LENS
Applicant
Ocular Instruments, Inc.
Decision
Substantially Equivalent
Date received
1991-01-18
Decision date
1991-01-28
Days to decision
10 days
Clearance type
Traditional
Product code
HJK
Device class
2
Regulation number
886.1385
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Bellevue, WA, US
Third-party review
No
Expedited review
No

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VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D (K050623)Volk Optical, Inc.2005-03-28
DORC VITRECTOMY LENSES, MODEL 1284 SERIES (K033950)Dutch Ophthalmic Research Center (D.O.R.C.)2004-02-20
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (K030054)Fci Ophthalmics, Inc.2003-02-26
CONTACT LASER & DIAGNOSTIC LENSES (K023221)Volk Optical, Inc.2002-10-11
LUNEAU 3 MIRROR LENS (K022413)Luneau SA2002-09-24
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Recalls involving this device

No recalls on record reference this clearance.