# K034011: Gemini Surgical Laser System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Mar 30, 2004 after 97 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
201 later devices descend from it; 4 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Laserscope Lyra G Surgical Laser System and Accessories: named in the summary without a submission number
- (no number) Laserscope Aura 'DL' Series Surgical Laser Systems (KTP/532, KTPIYAG TM and Nd-YAGI1 064 Configurations): named in the summary without a submission number
- (no number) Laserscope Lyra Laser System and Accessories: named in the summary without a submission number

## Most influential descendants
- K070355: Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family (2008), 194 descendants of its own
- K083889: Fotona QX ND:Yag/KTP Laser System Family (2009), 166 descendants of its own
- K103455: Spectra Laser System (2011), 92 descendants of its own
- K093162: Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis, Powerlase at / Fidelis ER Iii D, HT Fid (2010), 83 descendants of its own
- K113588: Spectra Laser System (2012), 82 descendants of its own

## Indications for use
The Laserscope GeminiTM Laser System &Accessories is indicated for. KTP1532 Applications: Dermatology: To treat moderate inflammatory Acne vulgaris. ND:YAGI1064 Applications: Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.

Source page: https://510kreport.com/device/K034011
Methodology: https://510kreport.com/methodology