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510(k) K935919

SUNGLASSES by Ja-Ru, Inc. — Product Code HQG

K935919 is an FDA 510(k) premarket notification submitted by Ja-Ru, Inc. for the device "SUNGLASSES". The FDA issued a decision of Substantially Equivalent on February 16, 1994. The device falls under product code HQG (Lens, Spectacle, Non-Custom (Prescription)), a Class I device regulated under 21 CFR 886.5844. Ja-Ru, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1994
Date Received
December 8, 1993
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 Ja-Ru, Inc.

  • K941682 — COOL KIDS BEADS AND SHADES (May 17, 1994)
  • K934402 — COOL KIDS MIRROR SHADES (January 25, 1994)
  • K935165 — BIKER MICE SUNGLASSES (January 6, 1994)
  • K934852 — COOL KIDS HIP SHADES (December 8, 1993)
  • K931389 — ITEM # 754 HOT FLIP SHADES (October 6, 1993)

Other clearances for product code HQG

  • 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)
  • K872506 — MELANITE I (July 27, 1987)

FDA data resources