The following data is part of a premarket notification filed by Ultralite with the FDA for Ultralite Hf1236 Hand And Foot System.
| Device ID | K861963 |
| 510k Number | K861963 |
| Device Name: | ULTRALITE HF1236 HAND AND FOOT SYSTEM |
| Classification | Light, Ultraviolet, Dermatological |
| Applicant | ULTRALITE 390 FARMER CT. Lawrenceville, GA 30245 |
| Contact | William C Mcmillan |
| Correspondent | William C Mcmillan ULTRALITE 390 FARMER CT. Lawrenceville, GA 30245 |
| Product Code | FTC |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-25 |