FDA product code FSR: Light, Headband, Surgical
FSR is the FDA product code for light, headband, surgical. It is a Class II device, regulated under 21 CFR 886.4335 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under FSR, from 3 different applicants. The average 510(k) review took 96 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | Light, Headband, Surgical |
| Device class | Class II |
| Regulation | 21 CFR 886.4335 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FSR clearance
Top FSR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Welch Allyn, Inc. | 2 | 2003-08-11 |
| Integra LifeSciences Corporation | 1 | 2011-05-11 |
| Angiolaz, Inc. | 1 | 2000-05-11 |
Most recent FSR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K110528 | Integra LifeSciences Corporation | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | 2011-05-11 | 76 |
| K031549 | Welch Allyn, Inc. | SOLID STATE LAMP [LED] HEADLIGHT | 2003-08-11 | 87 |
| K031548 | Welch Allyn, Inc. | LED HEADLIGHT | 2003-08-11 | 87 |
| K994362 | Angiolaz, Inc. | HEADLAMP HL2000. | 2000-05-11 | 136 |
Recalls for FSR devices
openFDA lists no recalls for product code FSR.
Frequently asked questions
What is FDA product code FSR?
FSR is the FDA product code for light, headband, surgical. It is a Class II device, regulated under 21 CFR 886.4335 and reviewed by the Ophthalmic panel.
What device class is FSR?
Class II, regulation 21 CFR 886.4335. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSR?
Across 4 cleared submissions the average was 96 days from receipt to decision (median 87).
Which companies have the most FSR clearances?
Welch Allyn, Inc. (2); Integra LifeSciences Corporation (1); Angiolaz, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FSR
- Run a recall and safety report across every FSR manufacturer
- Watch product code FSR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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