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510(k) K021419

AART MALAR IMPLANT by Aesthetic and Reconstructive Technologies, Inc. — Product Code LZK

K021419 is an FDA 510(k) premarket notification submitted by Aesthetic and Reconstructive Technologies, Inc. for the device "AART MALAR IMPLANT". The FDA issued a decision of Substantially Equivalent on July 2, 2002. The device falls under product code LZK (Implant, Malar), a Class II device regulated under 21 CFR 878.3550. Aesthetic and Reconstructive Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
May 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Malar
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Aesthetic and Reconstructive Technologies, Inc.

  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K022511 — AART CALF IMPLANT (August 26, 2002)
  • K022223 — AART SILICONE SHEETING (August 8, 2002)
  • K021839 — AART GLUTEAL IMPLANT (July 16, 2002)
  • K021820 — AART SILICONE CARVING BLOCK (July 16, 2002)
  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K021417 — AART CHIN IMPLANT (July 2, 2002)

Other clearances for product code LZK

  • K002886 — IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) (November 24, 2000)
  • K992240 — PILLAR MALAR IMPLANT (November 22, 1999)
  • K983756 — SURGIFORM ANATOMICAL MALAR (November 20, 1998)
  • K982763 — SEARE BIOMEDICAL MALAR IMPLANTS (September 30, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K980140 — SPECTRUM DESIGNS MEDIAL MALAR IMPLANT (March 3, 1998)
  • K980141 — SPECTRUM DESIGNS PROJECTION MALAR IMPLANT (March 3, 1998)
  • K980139 — SPECTRUM DESIGNS PROFILE MALAR IMPLANT (March 3, 1998)
  • K973502 — IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT (November 7, 1997)
  • K973574 — DURALASTIC ANATOMICAL MALAR IMPLANT (October 24, 1997)

FDA data resources