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510(k) K945346

MAKROLON 2405 GOGGLES (LIGHT AND DARK) by Universal Massage & Tanning, Inc. — Product Code HOY

K945346 is an FDA 510(k) premarket notification submitted by Universal Massage & Tanning, Inc. for the device "MAKROLON 2405 GOGGLES (LIGHT AND DARK)". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)), a Class I device regulated under 21 CFR 886.4750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
November 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device Class
Class I
Regulation Number
886.4750
Review Panel
OP
Submission Type

Other clearances for product code HOY

  • K132042 — AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND (April 28, 2014)
  • K050856 — LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM (May 31, 2005)
  • K971465 — NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (June 4, 1997)
  • K944700 — ARCTIC PREMIER SERIES (December 22, 1994)
  • K944857 — GOGGLE SAFEGUARD (December 15, 1994)
  • K945351 — SHIELD, EYE, OPHTHALMIC (December 13, 1994)
  • K942407 — AMCON SLIP IN MYDRIATIC SUNGLASSES (June 6, 1994)
  • K941829 — SUN FILTERS/SHIELDS (May 17, 1994)
  • K930347 — SHAIDS PROTECTIVE GLASSES (April 29, 1994)
  • K940213 — UNIVERSAL CUSHIONED METAL EYE SHIELD (March 24, 1994)

FDA data resources