FSR · Class II · 21 CFR 886.4335

FDA Product Code FSR: Light, Headband, Surgical

Leading manufacturers include Welch Allyn, Inc., Integra LifeSciences Corporation and Angiolaz, Inc..

4
Total
4
Cleared
97d
Avg days
2000
Since

FDA 510(k) Cleared Light, Headband, Surgical Devices (Product Code FSR)

4 devices
1–4 of 4
Cleared May 11, 2011
INTEGRA LED SURGICAL HEADLIGHT SYSTEM
K110528
Integra LifeSciences Corporation
Ophthalmic · 76d
Cleared Aug 11, 2003
LED HEADLIGHT
K031548
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Aug 11, 2003
SOLID STATE LAMP [LED] HEADLIGHT
K031549
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared May 11, 2000
HEADLAMP HL2000.
K994362
Angiolaz, Inc.
Ophthalmic · 136d

About Product Code FSR - Regulatory Context