Crystal Focus Emerald Laser SLT MCX 1.5 Convex Pro
FDA 510(k) K910027 · Biovision, Inc.
510(k) numberK910027
Submission
- Device name
- Crystal Focus Emerald Laser SLT MCX 1.5 Convex Pro
- Applicant
- Biovision, Inc.
Oakland, CA, US - Received
- January 3, 1991
- Decision date
- September 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Crystal Focus Emerald Laser SLT MCX 1.5 Convex Pro cleared by the FDA?
Crystal Focus Emerald Laser SLT MCX 1.5 Convex Pro (K910027) received a 510(k) decision of Substantially Equivalent on September 25, 1991, 265 days after the submission was received.
What is the product code of K910027?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.