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510(k) K944402

FOCOMETER by Lacrimedics, Inc. — Product Code HLJ

K944402 is an FDA 510(k) premarket notification submitted by Lacrimedics, Inc. for the device "FOCOMETER". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570. Lacrimedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
September 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Lacrimedics, Inc.

  • K161673 — LacriPro Punctum Plug (November 18, 2016)
  • K140026 — COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TEST (June 3, 2014)
  • K030300 — OPAQUE HERRICK LACRIMAL PLUG (May 9, 2003)
  • K021831 — OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-O (July 1, 2002)
  • K001737 — OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MM (June 19, 2000)
  • K963501 — HERRICK ULTIMATE PUNCTUM PLUG (April 14, 1997)
  • K963708 — HERRICK ULTIMATE PUNCTUM PLUG (April 14, 1997)
  • K896175 — HERRICK LACRIMAL PLUG TM. (January 22, 1990)
  • K895342 — COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST (November 2, 1989)
  • K890714 — LACRIMAL EFFICIENCY TEST (TM) (May 17, 1989)

Other clearances for product code HLJ

  • K142486 — HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 (May 18, 2015)
  • K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M2 (January 29, 2015)
  • K131959 — HEINE MINI 3000(R) OPHTHALMOSCOPE (March 7, 2014)
  • K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE (December 4, 2013)
  • K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS (October 30, 2013)
  • K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPE (March 22, 2013)
  • K093495 — OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS (November 19, 2010)
  • K070270 — PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 (November 5, 2007)
  • K052599 — 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25 (November 7, 2006)
  • K061278 — OPTYSE OPHTHALMOSCOPE (May 16, 2006)

FDA data resources