The following data is part of a premarket notification filed by Isolux America with the FDA for Isolux Surgical Headlight.
| Device ID | K991572 |
| 510k Number | K991572 |
| Device Name: | ISOLUX SURGICAL HEADLIGHT |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | ISOLUX AMERICA 1479 RAILHEAD BLVD. Naples, FL 34110 -8444 |
| Contact | Stuart L Mcghee |
| Correspondent | Stuart L Mcghee ISOLUX AMERICA 1479 RAILHEAD BLVD. Naples, FL 34110 -8444 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-05 |
| Decision Date | 1999-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 01816835024147 | K991572 | 000 |
| 01816835024130 | K991572 | 000 |
| 01816835024123 | K991572 | 000 |
| 01816835024116 | K991572 | 000 |
| 01816835024109 | K991572 | 000 |
| 01816835024093 | K991572 | 000 |
| 01816835024086 | K991572 | 000 |
| 00816835024070 | K991572 | 000 |