Solar Tone
FDA 510(k) K802304 · Bloomex International, Inc.
510(k) numberK802304
Submission
- Device name
- Solar Tone
- Applicant
- Bloomex International, Inc.
Mchenry, IL, US - Received
- September 23, 1980
- Decision date
- December 1, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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Questions and answers
When was Solar Tone cleared by the FDA?
Solar Tone (K802304) received a 510(k) decision of Substantially Equivalent on December 1, 1980, 69 days after the submission was received.
What is the product code of K802304?
The FDA product code is LEJ – Booth, Sun Tan, a Class II (moderate risk) device regulated under 21 CFR 878.4635.