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510(k) K920795

0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX by Optical Radiation Corp. — Product Code HQG

K920795 is an FDA 510(k) premarket notification submitted by Optical Radiation Corp. for the device "0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX". The FDA issued a decision of Substantially Equivalent on July 13, 1992. The device falls under product code HQG (Lens, Spectacle, Non-Custom (Prescription)), a Class I device regulated under 21 CFR 886.5844. Optical Radiation Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1992
Date Received
February 21, 1992
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 Radiation Corp.

  • K863200 — COMPUTON(R) (September 3, 1986)
  • K853668 — ORC ORACLE (October 15, 1985)

Other clearances for product code HQG

  • K935919 — SUNGLASSES (February 16, 1994)
  • 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)
  • K872506 — MELANITE I (July 27, 1987)

FDA data resources