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510(k) K873245

AR DIACOAT SINGLE VISION LENSES by Seiko Optical Products of America, Inc. — Product Code HQG

K873245 is an FDA 510(k) premarket notification submitted by Seiko Optical Products of America, Inc. for the device "AR DIACOAT SINGLE VISION LENSES". The FDA issued a decision of Substantially Equivalent on October 5, 1987. The device falls under product code HQG (Lens, Spectacle, Non-Custom (Prescription)), a Class I device regulated under 21 CFR 886.5844. Seiko Optical Products of America, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1987
Date Received
August 17, 1987
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 Seiko Optical Products of America, Inc.

  • K942513 — SEIKO EYEGLASS FRAME (July 15, 1994)
  • K900764 — SUNGLASS, NON-PRESCRIPTION (June 20, 1990)
  • K861684 — SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) (June 9, 1986)

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)
  • K872506 — MELANITE I (July 27, 1987)

FDA data resources