GentleMax Pro Plus
GUDID 00817495022970
GMPP with PPP
CANDELA CORPORATION
Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system| Primary Device ID | 00817495022970 |
| NIH Device Record Key | 4319c80b-c751-4a89-a7ca-44b48e748020 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GentleMax Pro Plus |
| Version Model Number | 9914-15-9036 |
| Company DUNS | 053468385 |
| Company Name | CANDELA CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817495022970 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201111
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-30 |
| Device Publish Date | 2022-05-20 |
On-Brand Devices [GentleMax Pro Plus]
| 00817495023083 | ASSY, FIBER, STANDARD, HC, GMPP |
| 00817495023076 | GMPP DCD Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly |
| 00817495023069 | GMPP ACC HP AIR CLIP Kit, w/o Fiber Assembly |
| 00817495023052 | GMPP DCD Small Spot Option Kit, w/Fiber Assembly |
| 00817495023045 | GMPP ACC Medium Spot Option Kit, w/Fiber Assembly |
| 00817495023038 | GMPP ACC Medium Spot Option Kit, w/Fiber Assembly |
| 00817495023021 | ASSY, DCD HAND PIECE, SMALL SPOT, GMPP |
| 00817495022994 | ASSY, ACC HAND PIECE, MEDIUM SPOT, GMPP |
| 00817495022970 | GMPP with PPP |
Trademark Results [GentleMax Pro Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENTLEMAX PRO PLUS 90168154 not registered Live/Pending |
Candela Corporation 2020-09-09 |
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