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510(k) K861162

LENS SPECTACLE NON-CUSTOM (PRESCRIPTION) by Efop — Product Code HQG

K861162 is an FDA 510(k) premarket notification submitted by Efop for the device "LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)". 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 1986
Date Received
March 28, 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 for product code HQG

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  • 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