Veinlase, Model E50-K8-B5, Spectrum K8, Model E50-K8-B9

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K000158 ↗

FDA Product Code

GEX

Models / Variants

E50-K8-B5

Spectrum K8

Model E50-K8-B9

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Dental 200, Dental 300, Dental 400, Models E-20, E-60, E-50

  Class II

  FDA 510(k) K991464 Active Cleared 20 Jul 1999

• Atlas-Elite, Model E-80, Corium 200, Corium 400, Model E-90, Elite, Model E-80-Ii, Elite Ultra, Model E-80-Iv

  Class II

  FDA 510(k) K990174 Active Cleared 1 Apr 1999

• PC Laser with Smart Plug (PC Edo & Dental 200)

  Class II

  FDA 510(k) K963124 Active Cleared 8 Nov 1996