Mychway Co. Ltd. · 89-08 · CHINA
For Mychway Co. Ltd., import alert is 89-08; country is CHINA; 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 Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device; product code is 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - RK Laser assisted lipolysis | 89 I - - SA Massager, Therapeutic, Electric; date published is 05/05/2013; address is Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA, verified against its source on 2026-09-30.
- Firm
- Mychway Co. Ltd. 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
- CHINA verified
- Address
- Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA verified
- Date published
- 05/05/2013 verified
- Product code
- 79 G - - FE Brush, Dermabrasion | 79 N - - ZF Massager, cosmetic, static electricity-emitting | 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager | 79 O - - RK Laser assisted lipolysis | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device | Laser Lipolysis Device each item verified
- FDA notes
- class II | class II | class II | Class II | class II each item verified
What the source says
Mychway Co. Ltd. Date Published : 05/05/2013 Pengdu Building Room 1701 , 126 Nanguang Road; Guangdong , Shenzhen, CHINA
— 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
79 G - - FE Brush, Dermabrasion Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: class II 79 N - - ZF Massager, cosmetic, static electricity-emitting Date Published: 11/08/2018 Desc: Laser Lipolysis Device Notes: class II 79 O - - OK Dermal cooling pack/vacuum/massager, Dermal cooling pack/vacuum/massager Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: class II 79 O - - RK Laser assisted lipolysis Date Published: 05/05/2013 Desc: Laser Lipolysis Device Notes: Class II 89 I - - SA Massager, Therapeutic, Electric Date Published: 05/05/2013 Desc: Laser Lipolysis Device 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