510(k) K971950
K971950 is an FDA 510(k) premarket notification submitted by Infinitech, Inc. for the device "INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER". The FDA issued a decision of Substantially Equivalent on August 1, 1997. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Infinitech, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1997
- Date Received
- May 28, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Ophthalmic
- Device Class
- Class II
- Regulation Number
- 886.4390
- Review Panel
- OP
- Submission Type