Simmons Shell

FDA 510(k) K855105 · Mira, Inc.

Substantially Equivalent

510(k) numberK855105

Submission

Device name
Simmons Shell
Applicant
Mira, Inc.
Waltham, MA, US
Received
December 23, 1985
Decision date
March 31, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HQT – Shell, Scleral
Device class
Class II (moderate risk)
Regulation
21 CFR 886.3800
Specialty
Ophthalmic
Implant
Yes

Other 510(k)s with product code HQT

510(k)DeviceApplicantDecision
K970327Scleral ShellHQT · Traditional Southwest Artificial Eyes, Inc.07/07/1997SE
K970320Scleral ShellHQT · Traditional Xavier A. Guerra, Ocularist, Inc.07/07/1997SE
K904961Artificial Scleral ShellHQT · Traditional Midwest Eye Laboratories, Inc.08/30/1991SE

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K941495Return Path Diathermy HandleHQR · Traditional 07/15/1994SE
K933527Modification of Anterior Segment ElectrodesHWA · Traditional 01/25/1994SE
K923629Ophthalmic Trichiasis ProbeHPS · Traditional 10/19/1992SE
K894248Converter SystemHQE · Traditional 02/27/1990SE
K891601Power Operated and Controlled Vitreous ScissorsHQE · Traditional 05/23/1989SE
K890448Light Source, Endoscop, Xenon ArcFFS · Traditional 05/08/1989SE
K863246MiraliteHQF · Traditional 10/31/1986SE
K863591Endophotocoagulation ProbeHQF · Traditional 10/10/1986SE

Questions and answers

When was Simmons Shell cleared by the FDA?

Simmons Shell (K855105) received a 510(k) decision of Substantially Equivalent on March 31, 1986, 98 days after the submission was received.

What is the product code of K855105?

The FDA product code is HQT – Shell, Scleral, a Class II (moderate risk) device regulated under 21 CFR 886.3800.