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510(k) K872620

SOLOS EYESITE DRAPES by Solos Ophthalmology — Product Code HMT

K872620 is an FDA 510(k) premarket notification submitted by Solos Ophthalmology for the device "SOLOS EYESITE DRAPES". The FDA issued a decision of Substantially Equivalent on July 31, 1987. The device falls under product code HMT (Drape, Patient, Ophthalmic), a Class II device regulated under 21 CFR 878.4370. 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
Drape, Patient, Ophthalmic
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Solos Ophthalmology

  • K874334 — SOLOS SINGLE USE TITANIUM TIP (January 11, 1988)
  • K872611 — SOLOS EYESITE CAP SLEEVE (August 10, 1987)
  • K872612 — SOLOS EYESITE SPONGES (July 31, 1987)
  • K872610 — SOLOS EYESITE CANNULAS (July 31, 1987)

Other clearances for product code HMT

  • K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE (February 14, 1995)
  • K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY (February 6, 1991)
  • K871706 — OPTHA PREP (May 18, 1987)
  • K854613 — SURGICAL DRAPES, OPHTHALMIN (February 13, 1986)
  • K831340 — DRAIN-R-DRAPE(EYE (June 8, 1983)
  • K830822 — EYE DRAPE (April 6, 1983)

FDA data resources