Ultraviolet Sun Tanning Lamp
FDA 510(k) clearance K151674 · decided 2015-10-20
Clearance details
- K-number
- K151674
- Device name
- Ultraviolet Sun Tanning Lamp
- Applicant
- G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh
- Decision
- Substantially Equivalent
- Date received
- 2015-06-22
- Decision date
- 2015-10-20
- Days to decision
- 120 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
- Berlin, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch G.I.E.- Gesellschaft Fur Lichttechnische Erzeugnisse Mbh
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.