BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
FDA 510(k) K152233 · Sportarredo Group S.C.
510(k) numberK152233
Submission
- Device name
- BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
- Applicant
- Sportarredo Group S.C.
Gruaro, IT - Received
- August 7, 2015
- Decision date
- January 27, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LEJ – Booth, Sun Tan
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4635
- Specialty
- General, Plastic Surgery
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More from Lpi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K161394 | HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega LuxLEJ · Traditional | 07/06/2017SE |
Questions and answers
When was BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux cleared by the FDA?
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux (K152233) received a 510(k) decision of Substantially Equivalent on January 27, 2016, 173 days after the submission was received.
What is the product code of K152233?
The FDA product code is LEJ – Booth, Sun Tan, a Class II (moderate risk) device regulated under 21 CFR 878.4635.