Atlas FDA

LLO

19 FDA 510(k) clearances · Product code

46 daysmedian time to decision
184 days90th percentile
19clearances measured

FDA profile

Official device name
Laser, Neodymium:Yag, Pulmonary Surgery
Device class
Class II (moderate risk)
Regulation
21 CFR 874.4500
Medical specialty
Ear, Nose, Throat
Flags
Third-party review eligible
Adverse events (MAUDE)
1992: 5 · 1994: 1 · 1995: 2 · 1996: 2 · 1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SLT CLMD CONTACT LASER (K884815)Surgical Laser Technologies, Inc.1988-12-22
SURGILASE YAG 100 FOR GYNECOLOGY USE (K881499)Surgilase, Inc.1988-04-29
LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE (K880592)Laser Peripherals, LLC1988-04-25
MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (K880170)Cooper Lasersonics, Inc.1988-03-24
ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS (K874254)Minnesota Laser Corp.1988-03-04
SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (K875104)Laserguide1988-02-02
MODEL 5050 SURGILASER FOR PULMONARY USE (K871876)Lasermatic, Inc.1988-01-22
FIBERLASE II ND:YAG LASER FOR PULMONARY USE (K872351)Laser Media1987-12-11
OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL (K870505)Trimedyne, Inc.1987-08-07
SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (K871511)Medical Energy, Inc.1987-07-21
6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (K862698)Cooper Lasersonics, Inc.1986-08-05
LASER BRONCHOSCOPE SYSTEM (K861921)Pilling Co.1986-06-02
CO2 LASER BRONCHOSCOPE SYSTEM (K861583)Richard Wolf Medical Instruments Corp.1986-05-21
MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT (K861045)Sharplan Industries, Inc.1986-04-23
S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA (K855095)Surgical Laser Technologies, Inc.1986-02-18
CILAS MODEL YM101 (K852761)Inframed, Inc.1985-11-14
ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION (K852507)Endo Lase, Inc.1985-07-05
LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS- (K850432)Cooper Lasersonics, Inc.1985-02-15
FIBERLASE 100 MEDICAL LASER SYSTEM (K844869)Laser Media1985-01-14

Track LLO automatically

Every clearance here is in the API, with alerts when new ones post.