Home / 510(k) Clearances / K973934

510(k) K973934

SUNGLASSES by Elegance Optical Manufactory, Ltd. — Product Code HQY

K973934 is an FDA 510(k) premarket notification submitted by Elegance Optical Manufactory, Ltd. for the device "SUNGLASSES". The FDA issued a decision of Substantially Equivalent on November 18, 1997. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1997
Date Received
October 15, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Device Class
Class I
Regulation Number
886.5850
Review Panel
OP
Submission Type

Other clearances for product code HQY

  • K974860 — NON-PRESCRIPTION SUNGLASSES (January 30, 1998)
  • K974852 — NON-PRESCRIPTION SUNGLASSES (January 30, 1998)
  • K974861 — NON-PRESCRIPTION SUNGLASSES (January 27, 1998)
  • K974511 — SUNGLASSES (January 12, 1998)
  • K974441 — SUNGLASSES (January 9, 1998)
  • K974414 — MULTI (December 8, 1997)
  • K973528 — SUNGLASSES (December 8, 1997)
  • K974179 — NON-PRESCRIPTION SUNGLASSES (December 1, 1997)
  • K974045 — VENNETO (November 20, 1997)
  • K973526 — SUNGLASSES (October 16, 1997)

FDA data resources