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510(k) K871961

MULTIPLE SPECTACLE LENS by Korea Asahi Optical Co., Ltd. — Product Code HQG

K871961 is an FDA 510(k) premarket notification submitted by Korea Asahi Optical Co., Ltd. for the device "MULTIPLE SPECTACLE LENS". The FDA issued a decision of Substantially Equivalent on June 3, 1987. The device falls under product code HQG (Lens, Spectacle, Non-Custom (Prescription)), a Class I device regulated under 21 CFR 886.5844. Korea Asahi Optical Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1987
Date Received
May 20, 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 Korea Asahi Optical Co., Ltd.

  • K871649 — CLASSIC 70 LENS (May 29, 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