uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
FDA 510(k) clearance K152364 · decided 2016-04-14
Clearance details
- K-number
- K152364
- Device name
- uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
- Applicant
- Pc Marketing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-21
- Decision date
- 2016-04-14
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- LEJ
- Device class
- 2
- Regulation number
- 878.4635
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ridgefield, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.