Guangzhou April Face Beauty LTD · 89-08 · CHINA
For Guangzhou April Face Beauty 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 Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin; 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 2026-09-30.
- Firm
- Guangzhou April Face Beauty 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
- GUANGZHOUSH YUEXIUQU JIANSHE DAMALU 22 HAO B DONG 3308 SHI CHINA , DAMALU 22, HAO 8 DONG CHINA verified
- Date published
- 07/28/2022 verified
- 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 each item verified
- Product
- Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin | Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber | Spa Fragrance Health Care Capsule; Chinese Medicine Fumigation Cabin each item verified
- 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 each item verified
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
— accessdata.fda.gov, retrieved 2026-09-22
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
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: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber 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 - - 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: Apollo 2.0; Apollo 3.0; LED Infrared Capsule Machine; LED Infrared Sweat Chamber 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html