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510(k) K854218

THE ULTRA-MATE LENS by Optical Systems Intl., Inc. — Product Code HQG

K854218 is an FDA 510(k) premarket notification submitted by Optical Systems Intl., Inc. for the device "THE ULTRA-MATE LENS". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code HQG (Lens, Spectacle, Non-Custom (Prescription)), a Class I device regulated under 21 CFR 886.5844. Optical Systems Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
October 17, 1985
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 Optical Systems Intl., Inc.

  • K843957 — ULTRATHIN/SP LENS (July 31, 1985)

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