# Zero Plus International Limited · 89-08 · HONG KONG SAR — FDA import alert red lists: firms subject to detention without physical examination

For Zero Plus International Limited · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; product is SL-50 Cluster Laser | SL-50 Cluster Laser | SL-50 Cluster Laser; product code is 79 G - - EX Powered laser surgical instruments | 79 O - - NF Powered light based non-laser surgical instrument with thermal effect | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy; date published is 07/11/2011; address is 10/F, 1004/Room , Join In Hang Sing Centre; 71 Container Port Road , Kwai Chung, New Territories HONG KONG SAR, verified against its source on 2026-09-16.

- **Firm:** Zero Plus International Limited _(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:** HONG KONG SAR _(verified: appears in the quote below)_
- **Address:** 10/F, 1004/Room , Join In Hang Sing Centre; 71 Container Port Road , Kwai Chung, New Territories HONG KONG SAR _(verified: appears in the quote below)_
- **Date published:** 07/11/2011 _(verified: appears in the quote below)_
- **Product code:** 79 G - - EX Powered laser surgical instruments | 79 O - - NF Powered light based non-laser surgical instrument with thermal effect | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy _(verified: each item appears in the quote below)_
- **Product:** SL-50 Cluster Laser | SL-50 Cluster Laser | SL-50 Cluster Laser _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Zero Plus International Limited Date Published : 07/11/2011 10/F, 1004/Room , Join In Hang Sing Centre; 71 Container Port Road , Kwai Chung, New Territories HONG KONG SAR 79 G - - EX Powered laser surgical instruments Date Published: 07/11/2011 Desc: SL-50 Cluster Laser Notes: Class II 79 O - - NF Powered light based non-laser surgical instrument with thermal effect Date Published: 07/11/2011 Desc: SL-50 Cluster Laser Notes: Class II 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 07/11/2011 Desc: SL-50 Cluster Laser Notes: Class II

## 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/).