Purebeau New Cosmetics Gmbh · 89-08 · GERMANY
For Purebeau New Cosmetics 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 Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles; product code is 50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C. | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 04 Tattoo Ink | 79 O - - AB System ablations, low energy direct current and accessories; date published is 11/01/2017; address is Mozartstr. 12 , Berlin, Berlin GERMANY, verified against its source on 2026-09-16.
- Firm
- Purebeau New Cosmetics 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
- Mozartstr. 12 , Berlin, Berlin GERMANY verified
- Date published
- 11/01/2017 verified
- Product code
- 50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C. | 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. | 53 Y - - 04 Tattoo Ink | 79 O - - AB System ablations, low energy direct current and accessories each item verified
- Product
- Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles | Fibroplast Pen 3.5 Thunder w/ Needles each item verified
- FDA notes
- Class II | Class II | Class II | Class II each item verified
What the source says
Purebeau New Cosmetics Gmbh Date Published : 11/01/2017 Mozartstr. 12 , Berlin, Berlin GERMANY 50 N - - 99 Colors For Cosmetic Use (Not Certified), N.E.C. Date Published: 11/01/2017 Desc: Fibroplast Pen 3.5 Thunder w/ Needles Notes: Class II 53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C. Date Published: 11/01/2017 Desc: Fibroplast Pen 3.5 Thunder w/ Needles Notes: Class II 53 Y - - 04 Tattoo Ink Date Published: 11/01/2017 Desc: Fibroplast Pen 3.5 Thunder w/ Needles Notes: Class II 79 O - - AB System ablations, low energy direct current and accessories Date Published: 11/01/2017 Desc: Fibroplast Pen 3.5 Thunder w/ Needles Notes: Class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html