Metal Halide Light Source Model LM 250
FDA 510(k) K915274 · Pentax Precision Instrument Corp.
510(k) numberK915274
Submission
- Device name
- Metal Halide Light Source Model LM 250
- Applicant
- Pentax Precision Instrument Corp.
Orangeburg, NY, US - Received
- November 25, 1991
- Decision date
- January 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FST – Light, Surgical, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Metal Halide Light Source Model LM 250 cleared by the FDA?
Metal Halide Light Source Model LM 250 (K915274) received a 510(k) decision of Substantially Equivalent on January 23, 1992, 59 days after the submission was received.
What is the product code of K915274?
The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.