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510(k) K881225

OPHTHALMIC SPECTACLE LENS BLANKS by Beta Optical Co, Inc. — Product Code HQG

K881225 is an FDA 510(k) premarket notification submitted by Beta Optical Co, Inc. for the device "OPHTHALMIC SPECTACLE LENS BLANKS". The FDA issued a decision of Substantially Equivalent on April 19, 1988. 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
April 19, 1988
Date Received
March 22, 1988
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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  • 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)
  • 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)
  • K872506 — MELANITE I (July 27, 1987)

FDA data resources