Multilase 2500 a
FDA 510(k) K920708 · Teknomed, Inc.
510(k) numberK920708
Submission
- Device name
- Multilase 2500 a
- Applicant
- Teknomed, Inc.
Danvers, MA, US - Received
- February 18, 1992
- Decision date
- November 5, 1992
- 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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|---|---|---|
| K925395 | Technomed Pulsolith 4000 Laser SystemLNK · Traditional | 05/21/1993SE |
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| K895178 | Technomed Pulsolith Laser SystemFFK · Traditional | 10/06/1989SE |
| K890436 | Technomed Pulsolith Laser SystemFFK · Traditional | 03/23/1989SE |
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Questions and answers
When was Multilase 2500 a cleared by the FDA?
Multilase 2500 a (K920708) received a 510(k) decision of Substantially Equivalent on November 5, 1992, 261 days after the submission was received.
What is the product code of K920708?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.