Zara Zone IV Malar Implant Modification
FDA 510(k) K934233 · Byron Medical
510(k) numberK934233
Submission
- Device name
- Zara Zone IV Malar Implant Modification
- Applicant
- Byron Medical
Tucson, AZ, US - Received
- August 30, 1993
- Decision date
- February 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LZK – Implant, Malar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code LZK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021419 | Aart Malar ImplantLZK · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)LZK · Traditional | Implantech Associates, Inc. | 11/24/2000SE |
| K992240 | Pillar Malar ImplantLZK · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983756 | Surgiform Anatomical MalarLZK · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982763 | Seare Biomedical Malar ImplantsLZK · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
| K981835 | Silimed Malar ImplantLZK · Traditional | Silimed, LLC | 07/09/1998SE |
| K980141 | Spectrum Designs Projection Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980140 | Spectrum Designs Medial Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K980139 | Spectrum Designs Profile Malar ImplantLZK · Traditional | Spectrum Designs, Inc. | 03/03/1998SE |
| K973502 | Implantech Conform Binder Submalar ImplantLZK · Traditional | Implantech Associates, Inc. | 11/07/1997SE |
More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040149 | Psi-Tec Peristaltic Infiltration PumpFRN · Traditional | 06/03/2004SE |
| K001803 | Accelerator Reciprocating CannulaQPB · Traditional | 08/04/2000SE |
| K981215 | Psi-Tec Liposuction AspiratorQPB · Traditional | 07/01/1998SE |
| K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesQPB · Traditional | 06/30/1998SE |
| K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationFRN · Traditional | 06/16/1998SE |
| K980392 | Psi-Tec AspiratorBTA · Traditional | 03/05/1998SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | 02/10/1998SE |
| K973133 | Big Bag 3000 Pressure InfusorFRN · Traditional | 09/12/1997ST |
| K934179 | Disposable Bag DecanterKPE · Traditional | 05/23/1994SE |
| K933670 | Biopsy Punch, SurgicalEME · Traditional | 01/07/1994SE |
Questions and answers
When was Zara Zone IV Malar Implant Modification cleared by the FDA?
Zara Zone IV Malar Implant Modification (K934233) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 157 days after the submission was received.
What is the product code of K934233?
The FDA product code is LZK – Implant, Malar, a Class II (moderate risk) device regulated under 21 CFR 878.3550.