GS STANDARD ENG · 89-08 · KOREA (THE REPUBLIC OF)
For GS STANDARD ENG, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 Mesotherapy Roller | Mesotherapy Roller | Mesotherapy Roller; product code is 53 - - - -- Cosmetics | 79 G - - ED Brush, Dermabrasion, Manual | 80 F - - MI Needle, Hypodermic, Single Lumen; date published is 11/29/2010; address is 1006, BYUCKSAN 2CHA, 481-10 , GASAN-DONG, GEUMCHEON-GU , SEOUL, KOREA (THE REPUBLIC OF), verified against its source on 2026-09-30.
- Firm
- GS STANDARD ENG 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 1006, BYUCKSAN 2CHA, 481-10 , GASAN-DONG, GEUMCHEON-GU , SEOUL, KOREA (THE REPUBLIC OF) verified
- Date published
- 11/29/2010 verified
- Product code
- 53 - - - -- Cosmetics | 79 G - - ED Brush, Dermabrasion, Manual | 80 F - - MI Needle, Hypodermic, Single Lumen each item verified
- Product
- Mesotherapy Roller | Mesotherapy Roller | Mesotherapy Roller each item verified
- FDA notes
- Class II | Class II | Class II each item verified
What the source says
GS STANDARD ENG Date Published : 11/29/2010 1006, BYUCKSAN 2CHA, 481-10 , GASAN-DONG, GEUMCHEON-GU , SEOUL, KOREA (THE REPUBLIC OF)
— 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
53 - - - -- Cosmetics Date Published: 11/29/2010 Desc: Mesotherapy Roller Notes: Class II 79 G - - ED Brush, Dermabrasion, Manual Date Published: 11/29/2010 Desc: Mesotherapy Roller Notes: Class II 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 11/29/2010 Desc: Mesotherapy Roller 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