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510(k) K861684

SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) by Seiko Optical Products of America, Inc. — Product Code HQG

K861684 is an FDA 510(k) premarket notification submitted by Seiko Optical Products of America, Inc. for the device "SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)". The FDA issued a decision of Substantially Equivalent on June 9, 1986. 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
June 9, 1986
Date Received
May 2, 1986
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)
  • K873245 — AR DIACOAT SINGLE VISION LENSES (October 5, 1987)

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