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510(k) K970318

OCULAR CONFORMER by Southwest Artificial Eyes, Inc. — Product Code HQN

K970318 is an FDA 510(k) premarket notification submitted by Southwest Artificial Eyes, Inc. for the device "OCULAR CONFORMER". The FDA issued a decision of Substantially Equivalent on July 7, 1997. The device falls under product code HQN (Conformer, Ophthalmic), a Class II device regulated under 21 CFR 886.3130. Southwest Artificial Eyes, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1997
Date Received
January 28, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conformer, Ophthalmic
Device Class
Class II
Regulation Number
886.3130
Review Panel
OP
Submission Type

Other clearances by Southwest Artificial Eyes, Inc.

  • K970327 — SCLERAL SHELL (July 7, 1997)

Other clearances for product code HQN

  • K972034 — MEDPOR OCULAR CONFORMER (January 20, 1998)
  • K970319 — OCULAR CONFORMER (July 7, 1997)
  • K945110 — KOLBERG OPHTHALMIC CONFORMER (January 13, 1995)
  • K921221 — STERILE/SINGLE USE SYMBLEPHARON RING (July 17, 1992)
  • K921229 — STERILE/SINGLE USE OPHTHALMIC CONFORMERS (June 9, 1992)
  • K772168 — MOLDEYE (November 30, 1977)

FDA data resources