Mlase Gmbh · 89-08 · GERMANY
For Mlase Gmbh · 89-08 · GERMANY, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is GERMANY; product is CCL Vario Demo For Trade Show | CCL Vario Demo Unit | CCL 365 Corneal Cross-Linking System | CCL 365 Vario Ultraviolet Lamp; | Phoenix Demo for Trade Show | UV-Lamp for Animal Use | UV Lamp | CCL Vario Demo Unit | Phoenix Demo for Trade Show | CCL 365 Vario Ultraviolet Lamp | CCL 365 Corneal Cross-Linking System | CCL Vario Demo For Trade Show | CCL 365 Corneal Cross-Linking System | CCL 365 Vario Ultraviolet Lamp | Phoenix Demo for Trade Show | CCL Vario Demo Unit | CCL Vario Demo For Trade Show | UV-Lamp for Animal Use | UV Lamp; product code is 79 F - - TC Light, Ultraviolet, Dermatological | 79 F - - TC Light, Ultraviolet, Dermatological | 79 F - - TC Light, Ultraviolet, Dermatological | 79 F - - TC Light, Ultraviolet, Dermatological | 79 F - - TC Light, Ultraviolet, Dermatological | 79 R - - EG Suntan lamp | 79 R - - EG Suntan lamp | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 95 R - - HW Uv lamp for home or business uses | 95 R - - HW Uv lamp for home or business uses; date published is 10/16/2015; address is Industrie Str. 17 , Germering, Bavaria GERMANY, verified against its source on 2026-09-16.
- Firm
- Mlase Gmbh verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- GERMANY verified
- Address
- Industrie Str. 17 , Germering, Bavaria GERMANY verified
- Date published
- 10/16/2015 verified
- Product code
- 79 F - - TC Light, Ultraviolet, Dermatological | 79 F - - TC Light, Ultraviolet, Dermatological | 79 F - - TC Light, Ultraviolet, Dermatological | 79 F - - TC Light, Ultraviolet, Dermatological | 79 F - - TC Light, Ultraviolet, Dermatological | 79 R - - EG Suntan lamp | 79 R - - EG Suntan lamp | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 H - - RJ Table, Instrument, Powered, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 86 N - - FJ System, Image Management, Ophthalmic | 95 R - - HW Uv lamp for home or business uses | 95 R - - HW Uv lamp for home or business uses each item verified
- Product
- CCL Vario Demo For Trade Show | CCL Vario Demo Unit | CCL 365 Corneal Cross-Linking System | CCL 365 Vario Ultraviolet Lamp; | Phoenix Demo for Trade Show | UV-Lamp for Animal Use | UV Lamp | CCL Vario Demo Unit | Phoenix Demo for Trade Show | CCL 365 Vario Ultraviolet Lamp | CCL 365 Corneal Cross-Linking System | CCL Vario Demo For Trade Show | CCL 365 Corneal Cross-Linking System | CCL 365 Vario Ultraviolet Lamp | Phoenix Demo for Trade Show | CCL Vario Demo Unit | CCL Vario Demo For Trade Show | UV-Lamp for Animal Use | UV Lamp each item verified
What the source says
Mlase Gmbh Date Published : 10/16/2015 Industrie Str. 17 , Germering, Bavaria GERMANY 79 F - - TC Light, Ultraviolet, Dermatological Date Published: 10/16/2015 Desc: CCL Vario Demo For Trade Show Notes: 79 F - - TC Light, Ultraviolet, Dermatological Date Published: 10/16/2015 Desc: CCL Vario Demo Unit Notes: 79 F - - TC Light, Ultraviolet, Dermatological Date Published: 10/16/2015 Desc: CCL 365 Corneal Cross-Linking System Notes: 79 F - - TC Light, Ultraviolet, Dermatological Date Published: 10/16/2015 Desc: CCL 365 Vario Ultraviolet Lamp; Notes: 79 F - - TC Light, Ultraviolet, Dermatological Date Published: 10/16/2015 Desc: Phoenix Demo for Trade Show Notes: 79 R - - EG Suntan lamp Date Published: 01/23/2019 Desc: UV-Lamp for Animal Use Notes: 79 R - - EG Suntan lamp Date Published: 01/23/2019 Desc: UV Lamp Notes: 86 H - - RJ Table, Instrument, Powered, Ophthalmic Date Published: 10/16/2015 Desc: CCL Vario Demo Unit Notes: 86 H - - RJ Table, Instrument, Powered, Ophthalmic Date Published: 10/16/2015 Desc: Phoenix Demo for Trade Show Notes: 86 H - - RJ Table, Instrument, Powered, Ophthalmic Date Published: 10/16/2015 Desc: CCL 365 Vario Ultraviolet Lamp Notes: 86 H - - RJ Table, Instrument, Powered, Ophthalmic Date Published: 10/16/2015 Desc: CCL 365 Corneal Cross-Linking System Notes: 86 H - - RJ Table, Instrument, Powered, Ophthalmic Date Published: 10/16/2015 Desc: CCL Vario Demo For Trade Show Notes: 86 N - - FJ System, Image Management, Ophthalmic Date Published: 10/16/2015 Desc: CCL 365 Corneal Cross-Linking System Notes: 86 N - - FJ System, Image Management, Ophthalmic Date Published: 10/16/2015 Desc: CCL 365 Vario Ultraviolet Lamp Notes: 86 N - - FJ System, Image Management, Ophthalmic Date Published: 10/16/2015 Desc: Phoenix Demo for Trade Show Notes: 86 N - - FJ System, Image Management, Ophthalmic Date Published: 10/16/2015 Desc: CCL Vario Demo Unit Notes: 86 N - - FJ System, Image Management, Ophthalmic Date Published: 10/16/2015 Desc: CCL Vario Demo For Trade Show Notes: 95 R - - HW Uv lamp for home or business uses Date Published: 10/16/2015 Desc: UV-Lamp for Animal Use Notes: 95 R - - HW Uv lamp for home or business uses Date Published: 10/16/2015 Desc: UV Lamp Notes:
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html