Reference Source

Guangzhou April Face Beauty LTD · 89-08 · CHINA

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
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 | 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 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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

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