Softcure 96
FDA 510(k) K170068 · Wellray Medical Laser, Inc.
510(k) numberK170068
Submission
- Device name
- Softcure 96
- Applicant
- Wellray Medical Laser, Inc.
Wardensville, WV, US - Received
- January 9, 2017
- Decision date
- May 5, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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Questions and answers
When was Softcure 96 cleared by the FDA?
Softcure 96 (K170068) received a 510(k) decision of Substantially Equivalent on May 5, 2017, 116 days after the submission was received.
What is the product code of K170068?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.