# Beijing Toplaser Technology Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Beijing Toplaser Technology Co., Ltd. · 89-08 · CHINA, 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 CHINA; product is NannoLight MP-50 Intense Pulsed Light and Laser System; product code is 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 G - - EX Powered laser surgical instruments | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology; date published is 09/16/2009; address is East 3rd Floor, Building M7 , NO. 1 Jiuxianqiao Donglu , Beijing, Beijing CHINA, verified against its source on 2026-09-16.

- **Firm:** Beijing Toplaser Technology Co., Ltd. _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** East 3rd Floor, Building M7 , NO. 1 Jiuxianqiao Donglu , Beijing, Beijing CHINA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 73 - - - -- Anesthesiology | 74 - - - -- Cardiovascular | 76 - - - -- Dental | 77 - - - -- Ear,Nose And Throat | 78 - - - -- Gastroenterological & Urological | 79 G - - EX Powered laser surgical instruments | 79 - - - -- General & Plastic Surgery | 80 - - - -- General Hospital/Personal Use | 84 - - - -- Neurological | 85 - - - -- Obstetrical & Gynecological | 86 - - - -- Ophthalmic | 87 - - - -- Orthopedic | 89 - - - -- Physical Medicine | 90 - - - -- Radiology _(verified: each item appears in the quote below)_
- **Product:** NannoLight MP-50 Intense Pulsed Light and Laser System _(verified: appears in the quote below)_
- **FDA notes:** All devices. GPI = DE. 10/7/2008. CDRH has indicated DWPE of said products requiring 510k approval only if its being imported by Beijing Toplaser Technology Co. Ltd and have no cleared or pending 510ks with CDRH. | (includes a 1064 handpiece Long-Pulsed Nd;YAG laser); Class II; 9/1/2009 _(verified: each item appears in the quote below)_

## What the source says

> Beijing Toplaser Technology Co., Ltd. Date Published : 09/16/2009 East 3rd Floor, Building M7 , NO. 1 Jiuxianqiao Donglu , Beijing, Beijing CHINA 73 - - - -- Anesthesiology Date Published: 09/16/2009 Notes: All devices. GPI = DE. 10/7/2008. CDRH has indicated DWPE of said products requiring 510k approval only if its being imported by Beijing Toplaser Technology Co. Ltd and have no cleared or pending 510ks with CDRH. 74 - - - -- Cardiovascular Date Published: 09/16/2009 76 - - - -- Dental Date Published: 09/16/2009 77 - - - -- Ear,Nose And Throat Date Published: 09/16/2009 78 - - - -- Gastroenterological & Urological Date Published: 09/16/2009 79 G - - EX Powered laser surgical instruments Date Published: 01/30/2019 Desc: NannoLight MP-50 Intense Pulsed Light and Laser System Notes: (includes a 1064 handpiece Long-Pulsed Nd;YAG laser); Class II; 9/1/2009 79 - - - -- General & Plastic Surgery Date Published: 09/16/2009 80 - - - -- General Hospital/Personal Use Date Published: 09/16/2009 84 - - - -- Neurological Date Published: 09/16/2009 85 - - - -- Obstetrical & Gynecological Date Published: 09/16/2009 86 - - - -- Ophthalmic Date Published: 09/16/2009 87 - - - -- Orthopedic Date Published: 09/16/2009 89 - - - -- Physical Medicine Date Published: 09/16/2009 90 - - - -- Radiology Date Published: 09/16/2009

## 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/).