# Mlase Gmbh · 89-08 · GERMANY — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** Industrie Str. 17 , Germering, Bavaria GERMANY _(verified: appears in the quote below)_
- **Date published:** 10/16/2015 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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:

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).