CO2 Laser System
by Advanced Technology Laser Co., Ltd.
510(k) K101555
CO2 Laser System is a Class II device made by Advanced Technology Laser Co., Ltd., cleared under FDA 510(k) K101555 on 17 Sep 2010, 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 | NumberK101555 | Date17 Sep 2010 | StatusActive |
Official records
- FDA 510(k) database K101555
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- Withdrawn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 K101555
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 | |||
|---|---|---|---|---|
| ATL eBeam | eBeam | 06970507240121 | — | On the market |
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