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510(k) K142715

Sensor Medical Family of Vitrectomy Lenses and Products by Sensor Medical Technology, LLC — Product Code HJK

K142715 is an FDA 510(k) premarket notification submitted by Sensor Medical Technology, LLC for the device "Sensor Medical Family of Vitrectomy Lenses and Products". The FDA issued a decision of Substantially Equivalent on December 16, 2014. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385. Sensor Medical Technology, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2014
Date Received
September 22, 2014
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 Sensor Medical Technology, LLC

  • K152308 — Sensor Medical Single Use Tonometer Prism (October 13, 2015)
  • K140368 — FAMILY OF DISPOSABLE LENSES (April 29, 2014)

Other clearances for product code HJK

  • K201909 — RxSight Contact Lens (September 10, 2020)
  • K173944 — Endocular Viewing Lenses and Silicone Ring (October 25, 2018)
  • K151961 — Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens (August 18, 2015)
  • 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