Purebeau New Cosmetics Gmbh · 89-08 · GERMANY
For Purebeau New Cosmetics 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 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
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.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html