FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AART MALAR IMPLANT
K Number: K021419
·
Decision Jul 2, 2002
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
39
Applicant Total
10
Review Days
60
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AART MALAR IMPLANT
- K Number
- K021419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3550
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aesthetic and Reconstructive Technologies, Inc.
- Date Received
- May 3, 2002
- Decision Date
- July 2, 2002
- Product Code
- LZK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZK | Implant, Malar | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZK), ordered by most recent decision date.
IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PILLAR MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SURGIFORM ANATOMICAL MALAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SEARE BIOMEDICAL MALAR IMPLANTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SILIMED MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Aesthetic and Reconstructive Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023678 | DIMISIL SCAR GEL | Jan 23, 2003 | Substantially Equivalent |
| K022306 | AART SILICONE TUBING | Oct 10, 2002 | Substantially Equivalent |
| K022511 | AART CALF IMPLANT | Aug 26, 2002 | Substantially Equivalent |
| K022223 | AART SILICONE SHEETING | Aug 8, 2002 | Substantially Equivalent |
| K021820 | AART SILICONE CARVING BLOCK | Jul 16, 2002 | Substantially Equivalent |
| K021839 | AART GLUTEAL IMPLANT | Jul 16, 2002 | Substantially Equivalent |
| K021337 | AART PECTORALIS IMPLANT | Jul 3, 2002 | Substantially Equivalent |
| K021417 | AART CHIN IMPLANT | Jul 2, 2002 | Substantially Equivalent |
| K021418 | AART NASAL IMPLANT | Jul 2, 2002 | Substantially Equivalent |