The following data is part of a premarket notification filed by Hgm Medical Laser Systems, Inc. with the FDA for Litespot(tm) Laser Indirect Ophthalmoscope.
| Device ID | K914484 |
| 510k Number | K914484 |
| Device Name: | LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Gregory R Mcarthur |
| Correspondent | Gregory R Mcarthur HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-08 |
| Decision Date | 1992-01-06 |