Home / 510(k) Clearances / K080788

510(k) K080788

VIVASCOPE SYSTEM, MODEL 1500, 3000 by Lucid, Inc. — Product Code PSN

K080788 is an FDA 510(k) premarket notification submitted by Lucid, Inc. for the device "VIVASCOPE SYSTEM, MODEL 1500, 3000". The FDA issued a decision of Substantially Equivalent on September 17, 2008. The device falls under product code PSN (Light Based Imaging), a Class II device regulated under 21 CFR 878.4580.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2008
Date Received
March 20, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Imaging
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type

Emission and collection of light to create an image for medical purposes

Other clearances for product code PSN

  • K230448 — DeepX DermoSight Dermatoscope (May 17, 2023)
  • K213957 — Demetra Dermatoscope BDEM-01 (March 11, 2022)
  • K201408 — Demetra Analytics Toolkit (February 18, 2021)
  • K192829 — Demetra BDEM-01 Dermatoscope (December 13, 2019)
  • K180162 — VivaScope System (May 3, 2018)
  • K062736 — SIASCOPE V (September 14, 2007)
  • K040171 — MICRODERM, MODEL/VERSION 3.5 (June 8, 2004)
  • K023729 — SIASCOPE II (February 3, 2003)
  • K011273 — SI ASCOPE (February 20, 2002)

FDA data resources