Ya-Man Laser 21
FDA 510(k) K032944 · Ya-Man, Ltd.
510(k) numberK032944
Submission
- Device name
- Ya-Man Laser 21
- Applicant
- Ya-Man, Ltd.
Leesburg, FL, US - Received
- September 22, 2003
- Decision date
- December 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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Questions and answers
When was Ya-Man Laser 21 cleared by the FDA?
Ya-Man Laser 21 (K032944) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 88 days after the submission was received.
What is the product code of K032944?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.