I.S.M. Product Family Model P2400C,A & Abc
FDA 510(k) K854171 · Intl. Solarium Manufacturer, Inc.
510(k) numberK854171
Submission
- Device name
- I.S.M. Product Family Model P2400C,A & Abc
- Applicant
- Intl. Solarium Manufacturer, Inc.
North Hollywood, CA, US - Received
- October 15, 1985
- Decision date
- November 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTC – Light, Ultraviolet, Dermatological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4630
- Specialty
- General, Plastic Surgery
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Questions and answers
When was I.S.M. Product Family Model P2400C,A & Abc cleared by the FDA?
I.S.M. Product Family Model P2400C,A & Abc (K854171) received a 510(k) decision of Substantially Equivalent on November 6, 1985, 22 days after the submission was received.
What is the product code of K854171?
The FDA product code is FTC – Light, Ultraviolet, Dermatological, a Class II (moderate risk) device regulated under 21 CFR 878.4630.