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510(k) K981235

OCULOSTAT by Laser Center Dev. Corp. — Product Code HNC

K981235 is an FDA 510(k) premarket notification submitted by Laser Center Dev. Corp. for the device "OCULOSTAT". The FDA issued a decision of Substantially Equivalent on July 15, 1998. The device falls under product code HNC (Specula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Laser Center Dev. Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1998
Date Received
April 3, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Laser Center Dev. Corp.

  • K981063 — AUTOMATED CORNEAL TREPHINE (June 23, 1998)

Other clearances for product code HNC

  • K022836 — STEPHENS DISPOSABLE SPECULUM (November 1, 2002)
  • K964289 — EYE FIXATION SPECULUM (December 17, 1996)
  • K863989 — THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (October 31, 1986)
  • K863664 — OPHTHALMIC SURGICAL SPECULUM (September 25, 1986)
  • K843196 — VISITEC EYE SPECULUM (October 5, 1984)
  • K830430 — EYELID SPECULUM (June 10, 1983)
  • K801969 — ASNIS GUIDED SCREW SYSTEMS (August 27, 1980)
  • K760849 — FELDSTEIN BLEPHAROSTOMY CLIP SQUARE (November 2, 1976)
  • K760848 — FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (November 2, 1976)
  • K760847 — FELDSTEIN BLEPHAROPLASTY CLIP SHARP P (November 2, 1976)

FDA data resources