510(k) K080158
- Device
- LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM
- Applicant
- LB MEDICAL L.L.C.
- 510(k) number
- K080158
- Product code
- LCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-05-02
- Date received
- 2008-01-23
- Regulation
- 510(k) Premarket Notification
- Classification name
- Expander, Skin, Inflatable
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRY SHERIDAN POWELL
- Address
- 901 King St., Suite 200 Alexandria VA US 22314 22314
FDA Registration Numbers#
- 3014334038
- 1058584
- 3010882686
- 1032347
- 9680411
- 9611112
- 3016851379
- 3006535925
- 3034525
- 1220246
- 3002579136
- 3008285983
- 2132242
- 3004215117
- 3005809810
- 3011137372
- 3013946322
- 3005067367
- 3014004349
- 9680741
- 9680890
- 1836161
- 3023244395
- 8040278
- 3003807268
- 3010041511
- 3008902714
- 1319639
- 3004135030
- 3022320321
- 2916714
- 3026387979
- 8010769
- 3007773213
- 3035366890
- 1722824
- 1526350
- 3002808145
- 3009134882
- 3007597038
- 3007185216
- 3012883202
- 9680718
- 3004608878
- 3019269298
- 1526534
- 8030607
- 3007738736
- 9613079
- 3010331645
- 3009548473
- 1822565
- 8043235
- 3003418325
- 3012852163
- 3011981870
- 3012507533
- 3030733800
- 9610612
- 3022177334
- 9611194
- 1222274
Source Documents#
Other 510(k) Records For Product Code LCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | 2026-01-16 |
| K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC | 2025-04-24 |
| K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2025-01-12 |
| K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2024-08-02 |
| K211676 | Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC | 2023-10-13 |
| K214124 | AlloX2 Pro Tissue Expanders | Sientra, Inc. | 2023-06-08 |
| K221127 | Sientra, inc. Portfinder | Sientra, Inc. | 2023-05-10 |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | 2018-12-21 |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC | 2018-09-25 |
| K182054 | Natrelle 133S Tissue Expander | Allergan | 2018-08-29 |
| K161483 | Unger Quad Injector | Stradis Healthcare | 2016-10-31 |
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | 2016-05-23 |
| K152496 | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | 2016-02-19 |
| K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015-08-20 |
| K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | 2015-04-24 |
Legacy Summary#
summary
FDA Review#
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