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510(k) K855105

SIMMONS SHELL by Mira, Inc. — Product Code HQT

K855105 is an FDA 510(k) premarket notification submitted by Mira, Inc. for the device "SIMMONS SHELL". The FDA issued a decision of Substantially Equivalent on March 31, 1986. The device falls under product code HQT (Shell, Scleral), a Class II device regulated under 21 CFR 886.3800. Mira, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1986
Date Received
December 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shell, Scleral
Device Class
Class II
Regulation Number
886.3800
Review Panel
OP
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)
  • K933527 — MODIFICATION OF ANTERIOR SEGMENT ELECTRODES (January 25, 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)

Other clearances for product code HQT

  • K970320 — SCLERAL SHELL (July 7, 1997)
  • K970327 — SCLERAL SHELL (July 7, 1997)
  • K904961 — ARTIFICIAL SCLERAL SHELL (August 30, 1991)

FDA data resources