Data / Medical devices / United States / B*g*makeovers Advanced Skin Care And SPA
B*g*makeovers Advanced Skin Care And SPA: FDA-registered device maker in Raymond, NH, United States, 4 510(k) clearances
B*g*makeovers Advanced Skin Care And SPA is registered with the FDA (registration 3027725665) in Raymond, NH, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 3, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3027725665
- Address
- BG Makeovers Advanced Skin Care, 6 Freetown Rd 2 6 Freetown Rd 2, Raymond, NH, United States, 03077
- Owner or operator
- B*G*MAKEOVERS Advanced Skin Care and Spa (10088521)
- Roles
- Repackager or relabeler
- First device listed
- August 7, 2023
- Registered through
- 2026
- Brand names listed
- Intense Pulse Light System, Platinum Pro HIFU, Platinum Pro PDT, Platinum Skin Pro Microneedling Pen, Skin Resurfacer Diamond Microdermabrasion, Ultimate Skin Refiner
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | 1 | Repackager or relabeler | accessdata.fda.gov |
| Brush, Dermabrasion, Powered | GFE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | OHV | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Powered Microneedle Device | QAI | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 3, 2023 | K230100 | SCIZER (SC1-M410) | OHV | Substantially Equivalent | Classys, Inc. | accessdata.fda.gov |
| August 11, 2023 | K230420 | Dr. pen Microneedling System | QAI | Substantially Equivalent | Guangzhou Ekai Electronic Technology Co., Ltd. | accessdata.fda.gov |
| May 21, 2020 | K200751 | Photodynamic Therapy (PDT) Equipment | GEX | Substantially Equivalent | Shangdong Huamei Technology Co., Ltd. | accessdata.fda.gov |
| January 22, 2013 | K122995 | INTENSE PULSED LIGHT (IPL) SYSTEMS | ONF | Substantially Equivalent | Beijing Kes Biology Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Brush, Dermabrasion, Manual
- All makers of Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
- All makers of Brush, Dermabrasion, Powered
- All makers of Powered Microneedle Device
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument
Updated November 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.