Product code

HLP: Target, fusion and stereoscopic

FDA product code · Class I · Ophthalmic

Key facts

Product code HLP
Device Target, fusion and stereoscopic
Device class Class I
Regulation number 886.1880
Review panel Ophthalmic
Medical specialty Ophthalmic
Submission type 510(K) Exempt
GMP exempt Yes

At a glance

  • 1–9 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • None UDI devices (GUDID)
  • 1–9 MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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