510(k) K021538
K021538 is an FDA 510(k) premarket notification submitted by Lightmed Corp. for the device "LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR". The FDA issued a decision of Substantially Equivalent on Aug 8, 2002. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Lightmed Corp. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 8, 2002
- Date Received
- May 10, 2002
- 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
- 510(k)