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510(k) K173944

Endocular Viewing Lenses and Silicone Ring by Phakos — Product Code HJK

K173944 is an FDA 510(k) premarket notification submitted by Phakos for the device "Endocular Viewing Lenses and Silicone Ring". The FDA issued a decision of Substantially Equivalent on October 25, 2018. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385. Phakos has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2018
Date Received
December 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class
Class II
Regulation Number
886.1385
Review Panel
OP
Submission Type

Other clearances by Phakos

  • K200911 — MIRA Adapter (June 2, 2020)
  • K180195 — Frigitronics adapter (March 16, 2018)
  • K162756 — PHAKOS Disposable Retinal Cryo Probe (May 3, 2017)

Other clearances for product code HJK

  • K201909 — RxSight Contact Lens (September 10, 2020)
  • K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (August 18, 2015)
  • K142715 — Sensor Medical Family of Vitrectomy Lenses and Products (December 16, 2014)
  • K051630 — SUPER VIEW DISPOSABLE BIOM LENS SET (June 29, 2005)
  • K051103 — HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY (June 7, 2005)
  • K050623 — VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK (March 28, 2005)
  • K033950 — DORC VITRECTOMY LENSES, MODEL 1284 SERIES (February 20, 2004)
  • K030054 — DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES (February 26, 2003)
  • K023221 — CONTACT LASER & DIAGNOSTIC LENSES (October 11, 2002)
  • K022413 — LUNEAU 3 MIRROR LENS (September 24, 2002)

FDA data resources