# Guangzhou April Face Beauty LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou April Face Beauty 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 Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber; product code is 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - MB Cabinet, Moist Steam | 89 I - - MB Cabinet, Moist Steam | 89 I - - OB Lamp, Infrared, Physical Medicine | 89 I - - OB Lamp, Infrared, Physical Medicine | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy; date published is 07/28/2022; address is GUANGZHOUSH YUEXIUQU JIANSHE DAMALU 22 HAO B DONG 3308 SHI CHINA , DAMALU 22, HAO 8 DONG CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou April Face Beauty 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:** GUANGZHOUSH YUEXIUQU JIANSHE DAMALU 22 HAO B DONG 3308 SHI CHINA , DAMALU 22, HAO 8 DONG CHINA _(verified: appears in the quote below)_
- **Date published:** 07/28/2022 _(verified: appears in the quote below)_
- **Product code:** 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - LY Lamp, infrared, therapeutic heating | 89 I - - MB Cabinet, Moist Steam | 89 I - - MB Cabinet, Moist Steam | 89 I - - OB Lamp, Infrared, Physical Medicine | 89 I - - OB Lamp, Infrared, Physical Medicine | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy | 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy _(verified: each item appears in the quote below)_
- **Product:** Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber _(verified: each item appears in the quote below)_
- **FDA notes:** For over the counter (OTC) use | For over the counter (OTC) use | For over the counter (OTC) use | For over the counter (OTC) use | For over the counter (OTC) use | For over the counter (OTC) use | For over the counter (OTC) use | For over the counter (OTC) use _(verified: each item appears in the quote below)_

## What the source says

> Guangzhou April Face Beauty LTD Date Published : 07/28/2022 GUANGZHOUSH YUEXIUQU JIANSHE DAMALU 22 HAO B DONG 3308 SHI CHINA , DAMALU 22, HAO 8 DONG CHINA 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 07/28/2022 Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber Notes: For over the counter (OTC) use 89 I - - LY Lamp, infrared, therapeutic heating Date Published: 07/28/2022 Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin Notes: For over the counter (OTC) use 89 I - - MB Cabinet, Moist Steam Date Published: 07/28/2022 Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin Notes: For over the counter (OTC) use 89 I - - MB Cabinet, Moist Steam Date Published: 07/28/2022 Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber Notes: For over the counter (OTC) use 89 I - - OB Lamp, Infrared, Physical Medicine Date Published: 07/28/2022 Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber Notes: For over the counter (OTC) use 89 I - - OB Lamp, Infrared, Physical Medicine Date Published: 07/28/2022 Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin Notes: For over the counter (OTC) use 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 07/28/2022 Desc: Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin Notes: For over the counter (OTC) use 89 N - - HN Lamp, Non-Heating, for Adjunctive Use in Pain Therapy Date Published: 07/28/2022 Desc: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber Notes: For over the counter (OTC) use

## 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/).