Mlase Gmbh · 89-08 · GERMANY

For Mlase Gmbh, import alert is 89-08; country is GERMANY; 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)"; product is CCL 365 Vario Ultraviolet Lamp; | Phoenix Demo for Trade Show | CCL Vario Demo For Trade Show | CCL Vario Demo Unit | CCL 365 Corneal Cross-Linking System | UV Lamp | UV-Lamp for Animal Use | CCL 365 Vario Ultraviolet Lamp | Phoenix Demo for Trade Show | 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 | CCL Vario Demo For Trade Show | CCL Vario Demo Unit | CCL 365 Corneal Cross-Linking System | UV Lamp | UV-Lamp for Animal Use; 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 2026-09-30.

What the source says

Mlase Gmbh Date Published : 10/16/2015 Industrie Str. 17 , Germering, Bavaria GERMANY

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.