Atlas FDA

Tanning Lamp

FDA 510(k) clearance K221523 · decided 2023-02-15

Clearance details

K-number
K221523
Device name
Tanning Lamp
Applicant
Unilam Co., Ltd.
Decision
Substantially Equivalent
Date received
2022-05-26
Decision date
2023-02-15
Days to decision
265 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
Ulsan Gwangyeogsi, KR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.