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510(k) K861960

ZIMLITE LENS by Asahi Optical Co. C/O Rosati Associates, P.C. — Product Code HQG

K861960 is an FDA 510(k) premarket notification submitted by Asahi Optical Co. C/O Rosati Associates, P.C. for the device "ZIMLITE 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. Asahi Optical Co. C/O Rosati Associates, P.C. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1986
Date Received
May 20, 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 Asahi Optical Co. C/O Rosati Associates, P.C.

  • K885133 — APACERAM ARTIFICIAL DENTAL IMPLANT (September 5, 1989)
  • K893134 — APACERAM OSSICULAR PROSTHESIS (August 3, 1989)
  • K872089 — APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G) (August 14, 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