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510(k) K003646

SUTUREGROOVE WEIGHT SIZING SET by Iop, Inc. — Product Code MML

K003646 is an FDA 510(k) premarket notification submitted by Iop, Inc. for the device "SUTUREGROOVE WEIGHT SIZING SET". The FDA issued a decision of Substantially Equivalent (kit) on February 22, 2001. The device falls under product code MML (Weights, Eyelid, External), a Class II device regulated under 21 CFR 886.5700. Iop, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 22, 2001
Date Received
November 27, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Weights, Eyelid, External
Device Class
Class II
Regulation Number
886.5700
Review Panel
OP
Submission Type

Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)

Other clearances by Iop, Inc.

  • K090078 — KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT (May 8, 2009)
  • K062252 — MOLTENO3 (September 27, 2006)
  • K053622 — SURGISIS OCULAR GRAFT (March 15, 2006)
  • K010852 — OSMED TISSUE EXPANDER (August 13, 2001)
  • K994289 — SUTUREGROOVE (April 17, 2000)
  • K972143 — MOA BONE / M-SPHERE (October 16, 1997)
  • K902489 — MODIFIED MOLTENO(TM) IMPLANTS (August 14, 1990)
  • K890598 — MOLTENO IMPLANT (February 27, 1989)

Other clearances for product code MML

  • K170591 — Altomed Malhotra Platinum Segments (June 6, 2017)
  • K150986 — Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants (August 17, 2015)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K011740 — CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) (July 2, 2001)
  • K011115 — KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL (May 2, 2001)
  • K001123 — KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 (April 21, 2000)
  • K994289 — SUTUREGROOVE (April 17, 2000)
  • K000127 — KURZ PURE GOLD UPPER EYELIDS IMPLANT (OBERASCHER), MODEL 4001 02-4001 10 (April 12, 2000)
  • K990224 — LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET (April 12, 1999)
  • K983607 — LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS (January 8, 1999)

FDA data resources