510(k) K871579
- Device
- MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
- Applicant
- SHARPLAN LASERS, INC.
- 510(k) number
- K871579
- Product code
- HHR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-11-16
- Date received
- 1987-04-23
- Regulation
- 884.4550
- Classification name
- Laser, Surgical, Gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN DALTON
- Address
- 1 Pearl Ct. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3004167969
- 9611102
- 3009736547
- 2938071
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HHR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881507 | ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES | Hgm Medical Laser Systems, Inc. | 1989-04-27 |
| K871875 | MODEL 5050 SURGILASER FOR OB-GYN USE | Lasermatic, Inc. | 1988-08-22 |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | Laser Engineering, Inc. | 1988-08-05 |
| K874615 | LASER CANNISTER FILTER | Medical Marketing, Inc. | 1988-06-23 |
| K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | Laser Peripherals, LLC | 1988-06-01 |
| K880930 | MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE | Copper Lasersonics, Inc. | 1988-05-31 |
| K880991 | LASER OPTICAL CATHETER SYSTEM | Medline Industries, Inc. | 1988-05-25 |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Cooper Lasersonics, Inc. | 1988-03-24 |
| K874837 | KTP/532 LASER FOR OB-GYN USE | Laserscope | 1988-03-14 |
| K875078 | HERACURE LS 500 | W.C. Heraeus GmbH | 1988-02-22 |
| K872709 | MODEL 20-C, RL-20A/U, OB-10A/U | Directed Energy, Inc. | 1988-02-02 |
| K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | Directed Energy, Inc. | 1988-02-02 |
| K864946 | ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE | Bio Quantum Technologies, Inc. | 1988-01-28 |
| K872352 | FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA | Laser Media | 1987-12-30 |
| K872253 | CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA | Surgical Laser Technologies, Inc. | 1987-10-06 |
Legacy Summary#
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FDA Review#
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