510(k) K210545
- Device
- Infrared Red Blue LED Light Heat Beauty Machine, Infrared Red Blue LED Light Heat Beauty Machine, Infrared Red Blue LED Light Heat Beauty Machine
- Applicant
- Marci Beauty Inc
- 510(k) number
- K210545
- Product code
- OLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-05-20
- Date received
- 2021-02-25
- 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
- Shaul Rappaport
- Address
- 4290 Cameron St. Unit 7 Las Vegas NV US 89103 89103
FDA Registration Numbers#
- 3015646995
- 3019015047
- 3014467408
- 3015289316
- 3021282523
- 3017618922
- 3035785623
- 3007689716
- 3021282471
- 3010402752
- 3027645761
- 3013423303
- 3010360273
- 3017953405
- 3042261413
- 3027651556
- 3030220360
- 3015603281
- 3030234143
- 3007744197
- 3015783545
- 3018949797
- 3017103444
- 3012512142
- 3013178978
- 3009102830
- 3020659203
- 2032513
- 3037031835
- 3008929787
- 3014386328
- 3030541658
- 3015924074
- 3038373471
- 3029083714
- 3016171836
- 3030194742
- 3037341611
- 3016879560
- 3011644607
- 3029944286
- 3017382141
- 3033850491
- 3033850489
- 3024892917
- 3007554929
- 3036720861
- 3016496662
- 3017422691
- 1832894
- 3012657194
- 3017619615
- 3015287734
- 3016904853
- 3033793026
- 3015619973
- 3008393409
- 3038214786
- 3013689783
- 3015974280
- 3016076077
- 3011547157
- 3013481783
- 3017140525
- 3012541016
- 3018994966
- 3044622318
- 3029972385
- 3023339103
- 3021599225
- 3007543044
- 3012104022
- 3042970900
- 3012386142
- 3013738756
- 3020900954
- 3014737458
- 3033847811
- 3004450661
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 |
| K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) | Shenzhen Eyco Technology Co., Ltd. | 2025-02-05 |
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases