510(k) K243555
- Device
- LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
- Applicant
- Shenzhen Eyco Technology Co., Ltd.
- 510(k) number
- K243555
- Product code
- OLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-05
- Date received
- 2024-11-18
- Regulation
- 878.4810
- Classification name
- Over-The-Counter Powered Light Based Laser For Acne
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ding Martin
- Address
- 2 /F, Bldg. 1, Jiashitai Science Park, 164# Fengtang Ave. Fuhai St., Baoan District, Shenzhen 518103, China Guangdong CN 518103 518103
FDA Registration Numbers#
- 3017140525
- 3015783545
- 3029083714
- 3014737458
- 3042970900
- 3044622318
- 1832894
- 3009765778
- 3017555752
- 3015619973
- 3035785623
- 3007744197
- 3030234143
- 3030234086
- 3018949797
- 3016076077
- 3015168585
- 3021282523
- 3021282471
- 3016879560
- 3020659203
- 3017382141
- 3018188770
- 3043126851
- 3017422691
- 3018994966
- 3020900954
- 3013481783
- 3015603281
- 3013689783
- 3017103444
- 3016750352
- 3015289316
- 3017649333
- 3006182559
- 3016171836
- 3016055197
- 3012104022
- 3019015047
- 3019864920
- 3009102830
- 3037031835
- 3008592814
- 3027651556
- 3015313684
- 3029972385
- 3013738756
- 3013178978
- 3012512142
- 3007689716
- 3015646995
- 3008393409
- 3012386142
- 3008929787
- 3029944286
- 3042261413
- 3027645761
- 3030220360
- 3037341611
- 3022327202
- 3016496662
- 3007543044
- 3016904853
- 3012327767
- 3033847811
- 3012657194
- 3031595583
- 1318319
- 3010360273
- 3038214786
- 3020491484
- 3011644607
- 3011564440
- 3033793026
- 3016071154
- 3033850491
- 3012541016
- 3017618922
- 3011547157
Source Documents#
Other 510(k) Records For Product Code OLP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026-03-04 |
| K251843 | Erchonia EVRL | Erchonia Corporation | 2025-09-12 |
| K242068 | LED Light Therapy Mask (RT01) | Ningbo Dechang Electrical Machinery Made Co.,Ltd | 2025-04-04 |
| K232656 | BLU TOTALE (Model: ENEOB852) | Premier North America, Inc. | 2023-11-14 |
| K230490 | PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT | Dongguan Hunter Electronic Technology Co., Ltd. | 2023-10-27 |
| K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | 2023-07-03 |
| K213056 | LED Facial Mask | Shenzhen Osto Technology Company Limited | 2022-07-07 |
| K220729 | The Luminance RED Acne Device | Luminance Medical Ventures, Inc. | 2022-06-09 |
| K213039 | Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | 2022-05-25 |
| K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine | Marci Beauty, Inc. | 2022-05-20 |
| K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022-03-22 |
| K210968 | reVive Light Therapy Essentials | Led Technologies, Inc. | 2021-12-21 |
| K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021-11-23 |
| K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-22 |
| K203271 | Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. | 2021-07-21 |