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510(k) K933527

MODIFICATION OF ANTERIOR SEGMENT ELECTRODES by Mira, Inc. — Product Code HWA

K933527 is an FDA 510(k) premarket notification submitted by Mira, Inc. for the device "MODIFICATION OF ANTERIOR SEGMENT ELECTRODES". The FDA issued a decision of Substantially Equivalent on January 25, 1994. The device falls under product code HWA (Impactor), a Class I device regulated under 21 CFR 888.4540. Mira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1994
Date Received
July 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Impactor
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Mira, Inc.

  • K951728 — SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE (March 19, 1997)
  • K950806 — SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS (June 5, 1996)
  • K941495 — RETURN PATH DIATHERMY HANDLE (July 15, 1994)
  • K923629 — OPHTHALMIC TRICHIASIS PROBE (October 19, 1992)
  • K894248 — CONVERTER SYSTEM (February 27, 1990)
  • K891601 — POWER OPERATED AND CONTROLLED VITREOUS SCISSORS (May 23, 1989)
  • K890448 — LIGHT SOURCE, ENDOSCOP, XENON ARC (May 8, 1989)
  • K863246 — MIRALITE (October 31, 1986)
  • K863591 — ENDOPHOTOCOAGULATION PROBE (October 10, 1986)
  • K855105 — SIMMONS SHELL (March 31, 1986)

Other clearances for product code HWA

  • K864422 — RAYLOR(TM) MALLET (November 24, 1986)
  • K841627 — MALLET (August 27, 1984)
  • K770205 — CEMENT CHISELS (February 8, 1977)

FDA data resources