Argon Microsurigal Protocols
FDA 510(k) K810740 · Lumenis, Inc.
510(k) numberK810740
Submission
- Device name
- Argon Microsurigal Protocols
- Applicant
- Lumenis, Inc.
Mchenry, IL, US - Received
- March 19, 1981
- Decision date
- August 21, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EWG – Laser, Ent Microsurgical Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4500
- Specialty
- Ear, Nose, Throat
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| K862866 | Model 10-C W/LP-10A/U & OS-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
| K862865 | Model 10-C W/LP-10A/U & OB-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
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Questions and answers
When was Argon Microsurigal Protocols cleared by the FDA?
Argon Microsurigal Protocols (K810740) received a 510(k) decision of Substantially Equivalent on August 21, 1981, 155 days after the submission was received.
What is the product code of K810740?
The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.