510(k) K870840
K870840 is an FDA 510(k) premarket notification submitted by Directed Energy, Inc. for the device "MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH". The FDA issued a decision of Substantially Equivalent on June 12, 1987. The device falls under product code EWG (Laser, Ent Microsurgical Carbon-Dioxide), a Class II device regulated under 21 CFR 874.4500. Directed Energy, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 1987
- Date Received
- February 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ent Microsurgical Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 874.4500
- Review Panel
- EN
- Submission Type