Creat Brand Skin Expander
FDA 510(k) K843678 · Aesthetech Corp.
510(k) numberK843678
Submission
- Device name
- Creat Brand Skin Expander
- Applicant
- Aesthetech Corp.
Paso Robles, CA, US - Received
- September 18, 1984
- Decision date
- November 6, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCJ – Tissue Expander And Accessories
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code LCJ
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|---|---|---|---|
| K254126 | Natrelle 133S Tissue ExpandersLCJ · Special | AbbVie | 01/16/2026SE |
| K242963 | MENTOR PliaForm Breast Tissue Expander w/ Suture TabsLCJ · Traditional | Mentor Worldwide, LLC | 04/24/2025SE |
| K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 01/12/2025SE |
| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 08/02/2024SE |
| K211676 | Motiva Flora SmoothSilk Tissue ExpanderLCJ · Traditional | Motiva USA, LLC | 10/13/2023SE |
| K214124 | AlloX2 Pro Tissue ExpandersLCJ · Traditional | Sientra, Inc. | 06/08/2023SE |
| K221127 | Sientra, inc. PortfinderLCJ · Traditional | Sientra, Inc. | 05/10/2023SE |
| K180826 | Natrelle 133 Plus MICROCELL Tissue ExpanderLCJ · Traditional | Allergan | 12/21/2018SE |
| K182335 | CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ · Special | Mentor Worldwide, LLC | 09/25/2018SE |
| K182054 | Natrelle 133S Tissue ExpanderLCJ · Special | Allergan | 08/29/2018SE |
More from Allergan
| 510(k) | Device | Decision |
|---|---|---|
| K873940 | Creat Brand O-Rise General AspiratorBTA · Traditional | 11/25/1987SE |
| K873434 | Creat Brand Malar ImplantLZK · Traditional | 09/11/1987SE |
| K853189 | Creat Brand I/A Pack Creat Brand Phaco PackHQC · Traditional | 09/24/1985SE |
| K841283 | Disposable Suction Tubing Set · Traditional | 04/24/1984SE |
| K812210 | Creat Brand Wagner Chin ImplantFWP · Traditional | 09/11/1981SE |
Questions and answers
When was Creat Brand Skin Expander cleared by the FDA?
Creat Brand Skin Expander (K843678) received a 510(k) decision of Substantially Equivalent on November 6, 1984, 49 days after the submission was received.
What is the product code of K843678?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.