Esc Medical Systems, Ltd.
Needham, MA, US
Esc Medical Systems , Ltd. appears in FDA device records in Needham, MA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Esc Medical Systems, Ltd. between 1996 and 2000. The busiest year on record is 1997, with 5. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 5 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K994014 | ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT | GEX | Substantially Equivalent | |
| K991935 | EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM | GEX | Substantially Equivalent | |
| K991628 | MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA | GEX | Substantially Equivalent | |
| K982119 | DIODE LASER | GEX | Substantially Equivalent | |
| K982827 | DERMA K ER:YAG/CO2 LASER | GEX | Substantially Equivalent | |
| K974536 | PHOTODERM HR SYSTEM | GEX | Substantially Equivalent | |
| K980537 | ND: YAG ACCESSORY FOR PHOTODERM SYSTEM | GEX | Substantially Equivalent | |
| K972872 | DERMA K LASER SYSTEM | GEX | Substantially Equivalent | |
| K972028 | DERMASCAN SURGICAL LASER SCANNER | GEX | Substantially Equivalent | |
| K963249 | EPILIGHT HAIR REMOVAL SYSTEM | GEX | Substantially Equivalent | |
| K964253 | DERMA 20 LASER SYSTEM | GEX | Substantially Equivalent | |
| K965015 | TOPAZ 30 SURGICAL LASER SYSTEM | GEX | Substantially Equivalent | |
| K960772 | PHOTODERM PL. | GEX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain