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510(k) K152238

Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5 by Sun Capsule, Inc. — Product Code LEJ

K152238 is an FDA 510(k) premarket notification submitted by Sun Capsule, Inc. for the device "Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5". The FDA issued a decision of Substantially Equivalent on March 4, 2016. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Sun Capsule, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2016
Date Received
August 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Booth, Sun Tan
Device Class
Class II
Regulation Number
878.4635
Review Panel
SU
Submission Type

Other clearances by Sun Capsule, Inc.

  • K871237 — SUN CAPSULE I & II SUNTANNING BOOTH (April 23, 1987)

Other clearances for product code LEJ

  • K221523 — Tanning Lamp (February 15, 2023)
  • K220500 — Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fit (July 1, 2022)
  • K191881 — KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun (October 28, 2019)
  • K190173 — Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hyb (May 10, 2019)
  • K183539 — Ergoline Sunrise 7200 Hybrid Technology (April 8, 2019)
  • K180555 — Ergoline Prestige 1600 Hybrid Performance (October 11, 2018)
  • K181455 — ProSun sunlamp products, Luxura sunlamp products (September 10, 2018)
  • K151721 — FIJI SUN FLUORESCENT TANNING UNIT (June 22, 2018)
  • K180581 — UV Lamps for Sunlamp Products (June 22, 2018)
  • K180576 — Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite an (April 19, 2018)

FDA data resources