Atlas FDA

EWG

24 FDA 510(k) clearances · Product code

99 daysmedian time to decision
188 days90th percentile
24clearances measured

FDA profile

Official device name
Laser, Ent Microsurgical Carbon-Dioxide
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: 1 · 1995: 1 · 1996: 1 · 1997: 3 · 1998: 2 · 1999: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BENSON CCA100 (K924652)Benson Medical Instruments Co.1993-04-09
LASERMATIC SURGILASER MODEL 5050 (K870587)Lasermatic OY1988-08-10
ILLUMINA 40 CO2 LASER SYSTEM (K880427)Cooper Lasersonics, Inc.1988-04-18
ILLUMINA 25 CO2 LASER SYSTEM (K880428)Cooper Lasersonics, Inc.1988-04-18
ILLUMINA 55 CO2 LASER SYSTEM (K880429)Cooper Lasersonics, Inc.1988-04-18
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT (K872710)Directed Energy, Inc.1987-09-24
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH (K870840)Directed Energy, Inc.1987-06-12
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) (K864975)Laserscope1987-02-25
MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (K862866)Directed Energy, Inc.1987-01-09
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE (K862865)Directed Energy, Inc.1987-01-09
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) (K862150)Directed Energy, Inc.1986-09-04
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER (K862005)Laserscope1986-08-29
MODEL 545-45 LASER FOR EAR, NOSE & THROAT (K860975)Britt Corp., Inc.1986-07-18
MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT (K860277)Britt Corp., Inc.1986-05-06
PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T (K854471)Minnesota Laser Corp.1986-02-13
ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY (K853875)Endo Lase, Inc.1986-01-09
ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY (K853902)Endo Lase, Inc.1986-01-09
FOR USE IN EAR; NOSE & THROAT MICROSURGERY (K852695)Minnesota Laser Corp.1985-08-30
MINUTEMAN CO2 MICROSURGICAL LASER OTO (K843514)American Surgical Laser, Inc.1984-12-04
CO2 SURGICAL LASER SYSTEM XML-10 (K841860)Xanar, Inc.1984-11-08
LASER GAS MIXTURES (K820535)Union Carbide Corp.1982-03-31
ARGON MICROSURIGAL PROTOCOLS (K810740)Lumenis, Inc.1981-08-21
VIDA 55 PULSE-ECHO ULTRASONIC DEVICE (K802279)Vida, Inc.1980-12-15
CO2 MICROSURGICAL LASER SYSTEM #370 (K802034)Metricon, Ltd.1980-10-10

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