Model 10-C With An SA-10B/U Optical Attachment
by Directed Energy, Inc. 510(k)
Active
510(k) K870970
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870970 | Date26 May 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Model 10-C With An SA-10B/U Optical Attachment is a medical device designed for use in general and plastic surgery applications. It functions as a specialized instrument to support clinical procedures within these surgical fields.
This device has received FDA 510(k) clearance. It is manufactured by Directed Energy, Inc. and is identified by the reference number K870970.
Other devices from Directed Energy, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the primary clinical application for the Model 10-C with SA-10B/U?
This device is specifically designed to support clinical procedures within the fields of general and plastic surgery.
What is the regulatory status of this device?
The Model 10-C with SA-10B/U Optical Attachment has received FDA 510(k) clearance under reference number K870970, indicating it has been found substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of this surgical instrument?
The device is manufactured by Directed Energy, Inc., located in Los Angeles, California.