Exilite
FDA 510(k) K150051 · BTL Industries, Inc.
510(k) numberK150051
Submission
- Device name
- Exilite
- Applicant
- BTL Industries, Inc.
Framingham, MA, US - Received
- January 12, 2015
- Decision date
- April 8, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONF – Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon…
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| K233473 | Deka LotusONF · Traditional | El.En S.P.A. | 05/16/2024SE |
| K233307 | Intensity Pulsed Light Therapy SystemONF · Traditional | Beijing Adss Development Co., Ltd. | 03/15/2024SE |
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Questions and answers
When was Exilite cleared by the FDA?
Exilite (K150051) received a 510(k) decision of Substantially Equivalent on April 8, 2015, 86 days after the submission was received.
What is the product code of K150051?
The FDA product code is ONF – Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, a Class II (moderate risk) device regulated under 21 CFR 878.4810.