Atlas FDA

LNK

60 FDA 510(k) clearances · Product code

80 daysmedian time to decision
207 days90th percentile
60clearances measured

FDA profile

Official device name
Laser For Gastro-Urology Use
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4810
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2005: 18 · 2006: 25 · 2007: 24 · 2008: 15 · 2009: 8 · 2010: 4
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
TECHNOMED PULSOLITH 4000 LASER SYSTEM (K925395)Teknomed, Inc.1993-05-21
MDL-2000 LASERTRIPTER (K901723)Candela Laser Corp.1990-07-13
ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI. (K874255)Minnesota Laser Corp.1988-07-12
ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA. (K874253)Minnesota Laser Corp.1988-07-12
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (K880256)Sharplan Lasers, Inc.1988-04-14
MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE (K880193)Sharplan Lasers, Inc.1988-04-14
ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (K875039)Surgilase, Inc.1988-04-13
MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (K880171)Cooper Lasersonics, Inc.1988-04-11
MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (K871934)Lasermatic, Inc.1988-03-25
MODEL 5050 SURGILASER FOR UROLOGY USE (K871932)Lasermatic, Inc.1988-03-25
SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (K873892)Laserguide1988-02-02
KTP/532 LASER (K873330)Laserscope1987-11-18
LASER OPTICAL FIBERS - DISPOSABLE (K872870)Optimed Therapeutics1987-10-14
SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE (K871865)Sharplan Lasers, Inc.1987-09-08
ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO. (K872630)Hgm, Inc.1987-08-25
FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE (K872350)Laser Media1987-08-10
UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM (K872031)Laser Media1987-08-04
SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI (K871513)Medical Energy, Inc.1987-07-09
SL-100 ND:YAG LASER FOR UROLOGIC SURGERY (K871516)Medical Energy, Inc.1987-07-09
SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING (K871515)Medical Energy, Inc.1987-07-09
SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID (K871514)Medical Energy, Inc.1987-07-09
SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE (K871348)Sharplan Lasers, Inc.1987-06-12
MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO. (K871029)Directed Energy, Inc.1987-05-18
MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO. (K871032)Directed Energy, Inc.1987-05-18
MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO. (K871030)Directed Energy, Inc.1987-05-15
10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH (K871031)Directed Energy, Inc.1987-05-15
ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE (K864948)Bio Quantum Technologies, Inc.1987-03-30
SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG (K863428)Laser Media1986-12-03
CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER (K863583)Laser Media1986-11-24
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM (K862598)Laserscope1986-11-19
CONTACT TIPS (K861955)Cooper Lasersonics, Inc.1986-08-14
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE (K861331)Trimedyne, Inc.1986-08-07
OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO (K861173)Trimedyne, Inc.1986-07-25
#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL (K861903)Cooper Lasersonics, Inc.1986-06-20
MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL (K861047)Sharplan Industries, Inc.1986-06-17
MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA (K861046)Sharplan Industries, Inc.1986-05-02
HGM, INC. LASERCATH (STERILE) (K860357)Hgm, Inc.1986-04-07
MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY (K860496)Xanar, Inc.1986-03-14
S.L.T. CONTACT LASER SYSTEM (K855100)Surgical Laser Technologies, Inc.1986-02-26
S.L.T. CONTACT LASER (K855119)Surgical Laser Technologies, Inc.1986-02-24
S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER (K854669)Surgical Laser Technologies, Inc.1986-02-11
ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM (K860063)Laser Media1986-02-05
MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY (K860152)Endo Lase, Inc.1986-02-05
FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM (K855197)Laser Media1986-01-21
LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM (K854027)Laserscope1985-12-02
HOTIP HEMOSTATIC PROBE (K843628)Trimedyne, Inc.1985-11-12
FIBERLASE 100 MEDICAL LASER SYSTEM (K852798)Laser Media1985-07-29
ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM (K850509)Laser Media1985-04-08
MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE (K850728)Cooper Lasersonics, Inc.1985-04-08
ND. YAG LASER RECTAL PATHOLOGY (K844460)Endo Lase, Inc.1985-01-16
ND:YAG LASER UROLOGICAL SURGERY (K844459)Endo Lase, Inc.1985-01-16
ND-YAG LASER FOR UROLOGICAL SURGERY (K843293)Endo Lase, Inc.1984-10-02
LASER FOR GENITOURINARY APPLIC. 4000 (K843240)Cooper Lasersonics, Inc.1984-10-02
ND-YAG LASER FOR PALLIATION OF GI MALIGN (K843374)Endo Lase, Inc.1984-10-02
BIOLAS YAG 100 CILAS, ERCELAS YAG 100 (K843156)Advanced Biomedical Instruments1984-10-01
COOPER LASERSONICS, 8000 ND.YAGLASER (K841869)Cooper Lasersonics, Inc.1984-08-08
YAG LASER 8000 - LOWER GI APPLICAT (K840142)Cooper Lasersonics, Inc.1984-05-18
FIBERLAS 100 MEDICAL SYSTEM (K833499)Fiberlase U.S.A.1984-04-02
MEDILAS LASER (K833557)Endo Lase, Inc.1984-02-07
MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000 (K833480)Cooper Lasersonics, Inc.1983-12-21

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