Light Scalpel
510(k) K141658
Light Scalpel is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Lightscalpel, LLC, cleared under FDA 510(k) K141658 on 22 Oct 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141658 | Date22 Oct 2014 | StatusActive |
Official records
- FDA 510(k) database K141658
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K141658
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| LightScalpel H-A110 | LS9002-02 / H-A110 | 00851842007074 | On the market | |
| LightScalpel H-S-T | LS9002-06 / H-S-T | 00851842007081 | On the market | |
| LightScalpel LS-1005 | LS9011-02, LS9011-03, LS9011-04, LS9030-01, LS9030-03, LS9036-01 / LS-1005 | 00851842007180 | On the market | |
| LightScalpel LS-2010 | LS9018-01, LS9018-04, LS9030-02, LS9030-05, LS9037-01, LS9037-02 / LS-2010 | 00851842007197 | On the market | |
| LightScalpel LS-20102-01 | 20102-01 / LS-20102-01 | 00851842007302 | On the market | |
| LightScalpel LS-20107-01 | 20107-01 / LS-20107-01 | 00851842007128 | On the market | |
| LightScalpel LS-20108-01 | 20108-01 / LS-20108-01 | 00851842007166 | On the market | |
| LightScalpel LS-20109-01 | 20109-01 / LS-20109-01 | 00851842007135 | On the market | |
| LightScalpel LS-20110-01 | 20110-01 / LS-20110-01 | 00851842007173 | On the market | |
| LightScalpel LS-20111-01 | 20111-01 / LS-20111-01 | 00851842007319 | On the market | |
| LightScalpel LS-20112-01 | 20112-01 / LS-20112-01 | 00851842007326 | On the market | |
| LightScalpel LS-20113-01 | 20113-01 / LS-20113-01 | 00851842007333 | On the market | |
| LightScalpel LS-4020 | LS9032-01, LS9038-01 / LS-4020 | 00851842007623 | On the market | |
| LightScalpel LS-F-1.0 | LS9000-05 / LS-F-1.0 | 00851842007005 | Length 1.0 m | On the market |
| LightScalpel LSA-FL | LS9013-01 / LSA-FL | 00851842007142 | On the market | |
| LightScalpel LSA-TR | LS9014-01 / LSA-TR | 00851842007159 | On the market | |
| LightScalpel LSF-175 | LS9007-01 / LSF-175 | 00851842007029 | Length 1.75 m | On the market |
| LightScalpel LSH-A110 | LS9010-02 / LSH-A110 | 00851842007104 | On the market | |
| LightScalpel LSH-ADJ | LS9016-01 / LSH-ADJ | 00851842007111 | On the market | |
| LightScalpel LSH-FA110 | LS9009-05 / LSH-FA110 | 00851842007067 | On the market | |
| LightScalpel LSH-FST | LS9009-03 / LSH-FST | 00851842007050 | On the market | |
| LightScalpel LSH-FST.25 | LS9009-01 / LSH-FST.25 | 00851842007036 | On the market | |
| LightScalpel LSH-FST.4 | LS9009-02 / LSH-FST.4 | 00851842007043 | On the market | |
| LightScalpel LSH-ST | LS9010-01 / LSH-ST | 00851842007098 | On the market |
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