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510(k) K812441

DI-CROWN by Coburn Optical Ind., Inc. — Product Code HQG

K812441 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "DI-CROWN". The FDA issued a decision of Substantially Equivalent on October 6, 1981. The device falls under product code HQG (Lens, Spectacle, Non-Custom (Prescription)), a Class I device regulated under 21 CFR 886.5844. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1981
Date Received
August 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Spectacle, Non-Custom (Prescription)
Device Class
Class I
Regulation Number
886.5844
Review Panel
OP
Submission Type

Other clearances by Coburn Optical Ind., Inc.

  • K892348 — MAGNILINK SYSTEM 201 (May 26, 1989)
  • K892351 — MAGNILINK SYSTEM 602 (May 26, 1989)
  • K892349 — MAGNILINK SYSTEM 209 (May 26, 1989)
  • K892350 — MAGNILINK SYSTEM 402/5 (May 26, 1989)
  • K892347 — MAGNILINK SYSTEM 101 (May 26, 1989)
  • K862188 — IRRIGATION & ASPIRATION/VITRECTOMY DEVICE (August 21, 1986)
  • K853457 — COBURN I/A SYSTEM (October 15, 1985)
  • K821737 — DISP. MICROSURGICAL KNIVES (July 2, 1982)
  • K803159 — AUTOMATED PERIMETERS (February 4, 1981)
  • K801659 — BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE (September 9, 1980)

Other clearances for product code HQG

  • K935919 — SUNGLASSES (February 16, 1994)
  • K920795 — 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX (July 13, 1992)
  • K900091 — MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR (April 4, 1990)
  • K884360 — SEIKO P-6 PROGRESSIVE SPECTACLE LENSES (November 15, 1988)
  • K882814 — NEOLENS PRESCRIPTION SPECTACLE LENS (July 29, 1988)
  • K882308 — CR-39 PLASTIC LENSES FOR EYEGLASSES (July 22, 1988)
  • K881225 — OPHTHALMIC SPECTACLE LENS BLANKS (April 19, 1988)
  • K875063 — SEIKO PLAX DIACOAT II & SEIKO PLAX S.V.P. (February 22, 1988)
  • K874681 — SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES (February 5, 1988)
  • K873245 — AR DIACOAT SINGLE VISION LENSES (October 5, 1987)

FDA data resources