Atlas FDA

HHR

48 FDA 510(k) clearances · Product code

98 daysmedian time to decision
341 days90th percentile
48clearances measured

FDA profile

Official device name
Laser, Surgical, Gynecologic
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4550
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1995: 1 · 1996: 1 · 1997: 1 · 1998: 1 · 2000: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (K881507)Hgm Medical Laser Systems, Inc.1989-04-27
MODEL 5050 SURGILASER FOR OB-GYN USE (K871875)Lasermatic, Inc.1988-08-22
GL-35 COLPOSCOPIC LASER SYSTEM (K875314)Laser Engineering, Inc.1988-08-05
LASER CANNISTER FILTER (K874615)Medical Marketing, Inc.1988-06-23
LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (K880591)Laser Peripherals, LLC1988-06-01
MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (K880930)Copper Lasersonics, Inc.1988-05-31
LASER OPTICAL CATHETER SYSTEM (K880991)Medline Industries, Inc.1988-05-25
MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (K880173)Cooper Lasersonics, Inc.1988-03-24
KTP/532 LASER FOR OB-GYN USE (K874837)Laserscope1988-03-14
HERACURE LS 500 (K875078)W.C. Heraeus GmbH1988-02-22
MODEL 20-C, RL-20A/U, OB-10A/U (K872709)Directed Energy, Inc.1988-02-02
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN (K870841)Directed Energy, Inc.1988-02-02
ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE (K864946)Bio Quantum Technologies, Inc.1988-01-28
FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA (K872352)Laser Media1987-12-30
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL (K872254)Surgical Laser Technologies, Inc.1987-12-14
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE (K871579)Sharplan Lasers, Inc.1987-11-16
CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA (K872253)Surgical Laser Technologies, Inc.1987-10-06
MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. (K871220)Cooper Lasersonics, Inc.1987-07-16
CO2 LASER MICROMANIPULATOR (K864378)Transamerican Technologies Intl.1987-03-05
DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET (K870046)Tti Medical1987-03-05
OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN (K863221)Laserscope1987-03-02
MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA (K863361)Cooper Lasersonics, Inc.1986-11-24
SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE (K862861)Directed Energy, Inc.1986-10-27
CO2 LASER MICROMANIPULATOR (K863520)Laser Spectrum, Inc.1986-10-06
FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA (K862444)Laser Media1986-09-25
CABOT LASER LAPAROSCOPY ACCESSORY SET (K862228)Cabot Medical Corp.1986-08-20
MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN (K862227)Hgm, Inc.1986-08-19
ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION (K862456)Cooper Lasersonics, Inc.1986-08-12
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE (K861845)Directed Energy, Inc.1986-08-11
MEDILAS 2 ND:YAG LASER SURGERY SYSTEM (K855093)Endo Lase, Inc.1986-02-21
ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY (K853876)Endo Lase, Inc.1986-02-21
ENDO-LASE CD40 CO2 FOR GYNECOLOGY (K853903)Endo Lase, Inc.1986-02-21
FYODOROV RADIAL KERATOTOMY MARKER SET (K860329)Med-Tech Develoment Corp.1986-02-12
PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI (K854470)Minnesota Laser Corp.1986-02-07
CO2 LASER LAPAROSCOPE SYSTEM (K854361)Richard Wolf Medical Instruments Corp.1986-02-04
MODEL J25-25 WATT CO2 LASER (K851425)Britt Corp., Inc.1985-11-12
PORTALASE 200 CARBON SURGICAL LASER SYSTEM (K852694)Minnesota Laser Corp.1985-09-30
ABDOMINAL PRESSURE CONTROL VALVE (K844829)L.A.S.E.R., Inc.1985-05-01
YN CO2 LASER SYSTEM 30W (K844431)Cryomedics, Inc.1985-02-25
CARBON DIOXIDE LASER ML 825 (K833528)Merrimack Laboratories1985-02-19
MINUTEMAN CO2 MICROSURGICAL LASER GYN (K843515)American Surgical Laser, Inc.1985-02-04
MONITOR CO2 LASER SYSTEM (K820261)Cooper Medical Corp.1982-03-05
CARBON DIOXIDE (C02) MICROSURGICAL LASER (K810562)Metricon, Ltd.1981-03-17
CO2 LASER (K801197)Advanced Biomedical Instruments1980-06-30
ML-800 CO2 (K800227)Merrimack Laboratories1980-03-03
LASER, CO2 SURGICAL (K782054)Cavitron Corp.1979-01-17
OB/GYN LASER, MODEL 920 (K772023)Photon Sources1977-11-18
COLPOSCOPICALLY DIRECTED OB/GYN LASER (K761347)Photon Sources1977-01-18

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