Q-CLEAR
FDA 510(k) clearance K110370 · decided 2011-09-15
Clearance details
- K-number
- K110370
- Device name
- Q-CLEAR
- Applicant
- Light Age, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-02-08
- Decision date
- 2011-09-15
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- PDZ
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Somerset, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Aspen Laser Systems Therapy Laser System (K150138) | Aspen Laser Systems, LLC | 2015-05-08 |
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| LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (K121508) | Fotona D.D. | 2012-12-12 |
| FREEDOM ND: YAG LASER SYSTEM (K113843) | Lutronic Corporation | 2012-09-27 |
| THE PL-1064 LASER SYSTEM (K120938) | Sheaumann Laser, Inc. | 2012-09-24 |
| FOTONA XP ND: YAG LASER SYSTEM (K113702) | Fotona D.D. | 2012-03-28 |
Recalls involving this device
No recalls on record reference this clearance.