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510(k) K950519

SILHOUETTE SUNLIMITED ADIDAS by Silhouette Optical , Ltd. — Product Code HQY

K950519 is an FDA 510(k) premarket notification submitted by Silhouette Optical , Ltd. for the device "SILHOUETTE SUNLIMITED ADIDAS". The FDA issued a decision of Substantially Equivalent on March 2, 1995. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Silhouette Optical , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1995
Date Received
February 6, 1995
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 by Silhouette Optical , Ltd.

  • K944160 — SILHOUETTE, SUNLIMETED,ADIDAS (September 28, 1994)

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)
  • K973934 — SUNGLASSES (November 18, 1997)

FDA data resources