25recent 510(k) rows retained153 source rows for OHS
4recall product rowspublic records, not a rate
OHSexact FDA product codeClass 2
CHRONOLOGICAL 510(K) RECORDS
Latest retained decisions.
LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)
Guangdong Newdermo Biotech Co., Ltd.
Substantially EquivalentK260946
LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Substantially EquivalentK254025
CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)
The Beauty Tech Group, Ltd.
Substantially EquivalentK260715
myLEDmask 2 (MJ-144)
Light Tree Ventures Europe B.V.
Substantially EquivalentK260415
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
NOOANCE
Substantially EquivalentK260150
LED Light Therapy Masks (LumiLips FAC07NA)
Guangdong Newdermo Biotech Co., Ltd.
Substantially EquivalentK260202
Ulike Reglow Light Therapy Device (UM10)
Shenzhen Ulike Smart Electronics Co., Ltd.
Substantially EquivalentK260511
LED Light Therapy Mask (Models: T2, RLD10)
Shenzhen Desida Technology Co., Ltd.
Substantially EquivalentK254079
LED Therapy Light (COB1400, HP1800PRO)
Shenzhen Hanhua Opto Co., Ltd.
Substantially EquivalentK253874
FAQ (LED Panel); FAQ (Dual LED Panel)
Foreo, Inc.
Substantially EquivalentK253683
RECALL DOCUMENTS
Retained product rows.
| Recall ID | Initiated | Status | Firm |
|---|---|---|---|
| Z-2975-2018 | 2018-06-29 | Terminated | Quasar Bio-Tech, Inc. |
| Z-2974-2018 | 2018-06-29 | Terminated | Quasar Bio-Tech, Inc. |
| Z-2973-2018 | 2018-06-29 | Terminated | Quasar Bio-Tech, Inc. |
| Z-1308-2009 | 2008-06-18 | Terminated | Sybaritic, Inc |