510(k) K843957
K843957 is an FDA 510(k) premarket notification submitted by Optical Systems Intl., Inc. for the device "ULTRATHIN/SP LENS". The FDA issued a decision of Substantially Equivalent on July 31, 1985. The device falls under product code HRG (Engine, Trephine, Accessories, Ac-Powered), a Class I device regulated under 21 CFR 886.4070. Optical Systems Intl., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1985
- Date Received
- October 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Engine, Trephine, Accessories, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 886.4070
- Review Panel
- OP
- Submission Type