Lad, Model LAD-01
FDA 510(k) K021222 · Norwood Abbey , Ltd.
510(k) numberK021222
Submission
- Device name
- Lad, Model LAD-01
- Applicant
- Norwood Abbey , Ltd.
Leesburg, FL, US - Received
- April 17, 2002
- Decision date
- January 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Lad, Model LAD-01 cleared by the FDA?
Lad, Model LAD-01 (K021222) received a 510(k) decision of Substantially Equivalent on January 8, 2003, 266 days after the submission was received.
What is the product code of K021222?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.