ST-302 Infrarex
FDA 510(k) K990233 · Skylark Device Co., Ltd.
510(k) numberK990233
Submission
- Device name
- ST-302 Infrarex
- Applicant
- Skylark Device Co., Ltd.
Taipei, TW - Received
- January 25, 1999
- Decision date
- October 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 ST-302 Infrarex cleared by the FDA?
ST-302 Infrarex (K990233) received a 510(k) decision of Substantially Equivalent on October 27, 1999, 275 days after the submission was received.
What is the product code of K990233?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.