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510(k) K872612

SOLOS EYESITE SPONGES by Solos Ophthalmology — Product Code HOZ

K872612 is an FDA 510(k) premarket notification submitted by Solos Ophthalmology for the device "SOLOS EYESITE SPONGES". The FDA issued a decision of Substantially Equivalent on July 31, 1987. The device falls under product code HOZ (Sponge, Ophthalmic), a Class II device regulated under 21 CFR 886.4790. Solos Ophthalmology has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1987
Date Received
July 6, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

Other clearances by Solos Ophthalmology

  • K874334 — SOLOS SINGLE USE TITANIUM TIP (January 11, 1988)
  • K872611 — SOLOS EYESITE CAP SLEEVE (August 10, 1987)
  • K872610 — SOLOS EYESITE CANNULAS (July 31, 1987)
  • K872620 — SOLOS EYESITE DRAPES (July 31, 1987)

Other clearances for product code HOZ

  • K132796 — SUNTOUCH EYE SPEAR (October 30, 2013)
  • K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (October 29, 2013)
  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K082460 — CENEFOM PVA SURGICAL SPEAR (December 15, 2008)
  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (June 26, 2001)
  • K003842 — PRESCOTT'S SURGICAL SPEAR (April 13, 2001)
  • K002279 — ML EYE SPEAR, MODEL ML 27 ES (August 18, 2000)
  • K993883 — M-PACT CORNEAL LIGHT SHIELD (December 21, 1999)
  • K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP (May 10, 1999)

FDA data resources