The following data is part of a premarket notification filed by Varitronics with the FDA for 360 Degree Fixation Light.
| Device ID | K933739 |
| 510k Number | K933739 |
| Device Name: | 360 DEGREE FIXATION LIGHT |
| Classification | Device, Fixation, Ac-powered, Ophthalmic |
| Applicant | VARITRONICS 620 PKWY. Broomall, PA 19008 |
| Contact | Wilfred Klein |
| Correspondent | Wilfred Klein VARITRONICS 620 PKWY. Broomall, PA 19008 |
| Product Code | HPL |
| CFR Regulation Number | 886.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-03 |
| Decision Date | 1994-03-14 |